The Landscape is a database of novel vaccine candidates designed to provide broader and more durable protection against circulating and pandemic influenza viruses, compared with current strain-specific seasonal influenza vaccines. CIDRAP is developing the landscape with support from the Global Funders Consortium for Universal Influenza Vaccine Development.
Database last updated on NOV 19, 2024
Database
Preclinical
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Phase 1
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Phase 2
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Phase 3
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Approved
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Platform
Influenza virus-based |
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16
Vaccines in
Preclinical
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2
Vaccines in
Phase 1
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3
Vaccines in
Phase 2
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0
Vaccines in
Phase 3
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0
Vaccines in
Approved
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Platform
Nucleic acid-based |
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32
Vaccines in
Preclinical
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6
Vaccines in
Phase 1
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5
Vaccines in
Phase 2
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4
Vaccines in
Phase 3
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0
Vaccines in
Approved
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Platform
Non-VLP nanoparticles |
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43
Vaccines in
Preclinical
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4
Vaccines in
Phase 1
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1
Vaccines in
Phase 2
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2
Vaccines in
Phase 3
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0
Vaccines in
Approved
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Platform
Recombinant proteins |
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41
Vaccines in
Preclinical
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1
Vaccines in
Phase 1
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3
Vaccines in
Phase 2
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1
Vaccines in
Phase 3
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0
Vaccines in
Approved
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Platform
Virus-like particles (VLP) |
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28
Vaccines in
Preclinical
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2
Vaccines in
Phase 1
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0
Vaccines in
Phase 2
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1
Vaccines in
Phase 3
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0
Vaccines in
Approved
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Platform
Virus-vectored |
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25
Vaccines in
Preclinical
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2
Vaccines in
Phase 1
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3
Vaccines in
Phase 2
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0
Vaccines in
Phase 3
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0
Vaccines in
Approved
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| Vaccine Name Sort descending | Developer / Location | Platform | Phase | Approach & Sources |
|---|---|---|---|---|
3M2e-3HA2-NP chimeric protein |
Korea Research Institute of Bioscience and Biotechnology (Korea) | Recombinant proteins | Preclinical | Chimeric protein targeting M2e, HA and NP viral proteins; aimed at inducing influenza virus-specific antibody responses, cytotoxic T lymphocyte activity, and antibody-dependent cellular cytotoxicity. |
3M2e-HA2-NP chimeric subunit |
Pasteur Institute of Iran (Iran) | Recombinant proteins | Preclinical | Recombinant chimeric protein 3M2e-HA2-NP containing conserved regions of M2e, HA, and NP derived from influenza A virus. |
3M2e-R4R5 |
University of Quebec at Montreal (Canada) | Non-VLP nanoparticles | Preclinical | An immunostimulating nanoparticle based on a fragment (R4R5) of the Curli-specific gene A (CsgA) protein that confers protection against influenza A virus when conjugated to three repeats of the highly conserved M2e epitope and administrated intranasally. |
3M2e-rHF nanoparticle |
Chinese Academy of Sciences (China) | Non-VLP nanoparticles | Preclinical | Tandem copies of M2e (3M2e) displayed on ferritin nanoparticles (recombinant human heavy chain ferritin, rHF); intranasal administration; aimed at stimulating cross-protective immunity through M2e-specific IgG antibodies, T-cell immune responses, and mucosal secretory-IgA antibodies. |
3M2e-T4 nanoparticle |
Huazhong Agricultural University (China) | Non-VLP nanoparticles | Preclinical | Insertion of Flu viral M2e into phage T4 genome through fusion to Soc (Small Outer Capsid protein) generated a recombinant phage, and the Soc-M2e proteins self-assembled onto phage capsids to form 3M2e-T4 nanoparticles during propagation of T4 in E. coli. |
3MCD-f nanovaccine |
Jilin University (China) | Non-VLP nanoparticles | Preclinical | Biepitope adjuvant-free, self-assembled influenza nanovaccine consisting of two conserved epitopes (M2e and CDhelix) |
A/NP+M2-rAd |
Food and Drug Administration (US) | Virus-vectored | Preclinical | Replication-deficient recombinant adenovirus-5 (rAd) vectors expressing conserved antigens NP and M2. |
AAV‐vectored HA or cHA |
Robert Koch Institute (Germany) | Virus-vectored | Preclinical | Adeno-associated virus (AAV) vectors expressing influenza virus HA or chimeric HA; aimed at inducing broadly protective antibodies. |
Ace-DEX microparticle |
University of North Carolina (US) | Non-VLP nanoparticles | Preclinical | M2e- and cyclic GMP-AMP (cGAMP)-encapsulated acetylated dextran (Ace-DEX) microparticles (MP); antigen-adjuvant combination is aimed at activation of humoral and cellular responses. |
Ad-5-H1 |
Icahn School of Medicine at Mount Sinai (US), University of Maryland (US) | Virus-vectored | Preclinical | Non-replicating adenoviral (Ad) vector, encoding a secreted form of H1 HA, aimed at eliciting cross-reactive stalk-mediated cellular and humoral immunity and protection. |
Ad4-H5-VTN |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Virus-vectored | Phase 1 | Replication-competent adenovirus type 4 encoding influenza virus H5 HA (Ad4-H5-Vtn) administered as an oral capsule or via tonsillar swab or nasal spray, as a potential platform for inducing durable and systemic mucosal immunity against influenza glycoproteins. Goal |
AdC68-cHAs |
Tianjin Medical University (China), Fudan University (China) | Virus-vectored | Preclinical | Novel cHAs comprising two or three fuzed head domains from different subtypes grafted onto one stalk domain, designated as cH1-H3, cH1-H7, cH1-H3-H7, and cH1-H7-H3 |
AdC68-CR9114 |
Fudan University (China) | Virus-vectored | Preclinical | Chimpanzee adenoviral vector, AdC68, expressing CR9114, a broadly neutralizing monoclonal antibody isolated form the peripheral blood mononuclear cells of healthy donors; CR9114 targets different types of influenza viruses. |
Adjuvanted nanoparticle fusion constructs |
Indian Institute of Science (India) | Non-VLP nanoparticles | Preclinical | Trimeric influenza stem domain immunogen, pH1HA10, displayed on the ferritin like protein MsDps2, Ferritin, and Encapsulin |
AH3–GFP |
Vaxsia Biomedical (Taiwan), University of Maryland Baltimore County (US) | Non-VLP nanoparticles | Preclinical | Self-assembled protein nanoparticle composed of a gain-of-function mutant of the AH3 peptide that enables temperature- and salt-dependent protein nanoparticle thermostability, intended to to stimulate a long-lasting humoral immune response, mediated by the presence of thermal stable protein nanoparticle that remains intact in the injection site |
AP-M2e/tri-stalk VLP |
Latvian Biomedical Research and Study Centre (Latvia) | Virus-like particles (VLP) | Preclinical | Panel of constructs based on HA tri-stalk and triple M2e (3M2e) antigens integrated into a bacteriophage AP205 VLP platform; aimed at broad protection against seasonal and novel influenza strains. |
B60-Stem-8071 |
Xiamen University (China) | Recombinant proteins | Preclinical |
An HA stem vaccine grafted with an epitope of broadly neutralizing antibodies CR8071 to stabilize the stem HA domain |
Bifluagen |
KJ Biosciences (US), Texas A&M University (US) | Non-VLP nanoparticles | Preclinical | Novel dual-domain nanoparticle fusion protein presenting two conserved antigens, M2e and HA2, on a nanoparticle protein; aimed at inducing cross protective immune responses. |
BP-NP366/PA224 |
University of Melbourne (Australia), Griffith University (Australia) | Non-VLP nanoparticles | Preclinical | Endotoxin-free production strain of E. coli bioengineered to assemble biopolymer particles (BPs) coated with conserved influenza antigens (BP-NP366/PA224). |
BP26-M2e nanobarrels |
Korea Advanced Institute of Science and Technology (Korea) | Non-VLP nanoparticles | Preclinical | Engineered monomeric BP26 monomers bearing an antigen aimed at promoting antigen-specific antibody production. |
BPL-1357 |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Influenza virus-based | Phase 1 | BPL-1357 contains 4 whole inactivated avian influenza virus strains: H7N3, H5N1, H3N8, and H1N9; administered either intranasally or intramuscularly; intended to induce mucosal immunity similar to the immune response following influenza infection including cellular and B cell responses. Goal |
Cap-Cat VLPs |
Henan Academy of Agricultural Sciences (China), Zhengzhou University (China) | Virus-like particles (VLP) | Preclinical | A generalized nanoantigen display platform, Cap-Cat virus-like particles (VLPs) displaying antigens such as M2e; aimed at providing cross-protection against diverse subtypes of influenza A virus strains. Formerly: Cap-M2e VLP |
CapM2e+Advax-SM |
Vaxine (Australia) | Recombinant proteins | Preclinical | M2e antigen based vaccine formulated with Advax-SM adjuvant administered to mothers aimed at inducing passive maternal protection to newborns |
CDh-f nanoparticle |
Jilin University (China) | Non-VLP nanoparticles | Preclinical | The A helix (Ah) and CD helix (CDh) from the HA stem were fused with ferritin, individually, or in tandem, yielding Ah-f, CDh-f and (A + CD)h-f nanoparticles (NPs), produced through a prokaryotic expression system. |
cGAMP-adjuvanted multivalent mRNA vaccines |
Georgia State University (US) | Nucleic acid-based | Preclinical | A multivalent influenza mRNA lipid nanoparticle (LNP) vaccine with mRNAs of hemagglutinins from influenza H1N1 and H3N2 viruses, matrix protein 1, and nucleoprotein, adjuvanted with cGAMP |
ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens |
Jenner Institute, University of Oxford (UK) | Virus-vectored | Phase 1 | Two-dose heterologous viral vectored constructs: modified vaccinia virus Ankara (MVA) and the chimpanzee adenovirus ChAdOx2 expressing conserved influenza virus antigens, nucleoprotein (NP) and matrix protein-1 (M1); aimed at stimulating T-cell responses to influenza virus. Goal |
ChAdOx1 NP+M1 prime, MVA-NP+M1 boost |
Icahn School of Medicine at Mount Sinai (US), Jenner Institute, University of Oxford (UK) | Virus-vectored | Preclinical | Influenza proteins cHA, NP, and M1 delivered by ChAdOx1 and MVA viral-vectored vaccines aimed at inducing potent T and B cell responses to confer broad protection. |
ChAdOx2-NPM1-NA2 and MVA-NPM1NA2 |
Pirbright Institute (UK) | Virus-vectored | Preclinical | Aerosol immunization with viral vectored vaccines (ChAdOx2 and MVA) expressing matrix (M1) and nucleoprotein (NP) |
cHAmg |
Academia Sinica (Taiwan), Scripps Research Institute (US), National Yang-Ming University (Taiwan) | Recombinant proteins | Preclinical | Monoglycosylated chimeric HA (cHAmg) with consensus H5 head and consensus H1 stem antigens or C34-adjuvanted monoglycosylated HA stem (HA stemmg); aimed at eliciting high titers of cross-reactive antibodies against a range of influenza strains and subtypes through CD4+ and CD8+ T cell responses. |
Chimeric cytokine HA-VLP vaccine |
Nerome Institute of Biological Resources (Japan) | Virus-like particles (VLP) | Preclinical | VLPs containing a chimeric cytokine (CC) comprising the M2 protein, influenza A neuraminidase stalk |
Chimeric HA constructs |
Icahn School of Medicine at Mount Sinai (US) | Influenza virus-based | Phase 2 | Sequential combinations of different platforms, including LAIVs and inactivated split vaccines, with adjuvants, or of chimeric (cHA) or mosaic (mHA) constructs (cHA-LAIV-LAIV and cHA-LAIV-IIV, M2e), consisting of “exotic” HA head domains (from avian influenza viruses) and a conserved stalk domain; sequential administration with cHAs with different head domains and the same stalk domain; aimed at focusing humoral immunity on the highly conserved HA stalk domain. (Formerly: cHA-based LAIV combinations) Goal Dong and Wang 2024 (PMID: 38788629), Bliss 2024 (PMID: 38805853), Edgar 2023 (PMID: 37871218), Puente-Massaguer 2023 (PMID: 37703367), Puente-Massaguer 2023 (PMID: 37342504), Meade 2022 (PMID: 36533948), Aydillo 2022 (PMID: 36496417), Zhu 2022 (PMID: 35594401), Isakova-Sivak 2022 (PMID: 35461523), Folschweiller 2022 (PMID: 35461522), Guthmiller 2021, Nachbagauer 2021 (PMID: 33288923), Liu 2021 (PMID: 33440898), Bernstein 2020 (PMID: 31630990), Destexhe 2020 (PMID: 32119974), Broecker 2019 (PMID: 31341648), Sun 2019 (PMID: 31540436), Krammer 2019 (PMID: 30715353), Nachbagauer 2019 (PMID: 31839997), Liu 2019 (PMID: 31105689), Choi 2019 (PMID: 31032479), Sunwoo 2018 (PMID: 30223475), Nachbagauer 2018 (PMID: 30044403), Nachbagauer 2017 (PMID: 29263881), Nachbagauer 2016 (PMID: 26719251), EudraCT: 2017-001584-20 (P1/2), NCT03275389 (P1), NCT03300050 (P1), NCT02415842 (Observational), Press Release 6-30-2022, Press Release 7-16-2020, Press Release 12-7-2020, Press Release 5-1-2019, News Story 12-7-2020, NIH Funding
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Chimeric HA protein |
University of Rochester Medical Center (US) | Recombinant proteins | Preclinical | Novel chimeric HA protein (cH7/3) comprised of the stem domain from seasonal H3 HA and the head domain from avian H7. |
Chimeric M2e nanoassemblies |
University of Quebec at Montreal (Canada) | Non-VLP nanoparticles | Preclinical | Nanofibril-based construct using a chimeric M2e peptide. |
CIC Vaccine |
Novavax (US) | Non-VLP nanoparticles | Phase 3 | Combination SARS-CoV-2 (COVID-19) and influenza vaccine that uses full-length, stabilized recombinant spike (rS) protein of the SARS-CoV-2 virus, and 4 wild-type recombinant Hemagglutinin (rHA) proteins from the influenza virus, as antigens. Goal Massare 2021, NCT06482359 (P3), NCT06291857 (P3), NCT05519839 (P2), NCT04961541 (P1/2), Development Update, Press Release 11-11-2024, Press Release 10-16-2024, Press Release 8-8-2024, Press Release 5-10-2024, Press Release 5-10-2024, Press Release 4-1-2024, Press Release 5-9-2023, Press Release 12-30-2022, Press Release 10-13-2022, Press Release 4-20-2022, Press Release 9-8-2021, Press Release 6-14-2021, Press Release 5-10-2021, News Story 5-9-2023, Novavax presentation Sep 2024, Novavax presentation Mar 2024, Novavax presentation Jan 2024, Novavax presentation 2023, Developer Website: Novavax
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Clec9A-M2e |
National University of Singapore (Singapore), Monash University (Australia) | Recombinant proteins | Preclinical | Targeting strategy that shuttles M2e to a specific dendritic cell subset (cDC1) by engineering a recombinant anti-Clec9A monoclonal antibody fused at each of its heavy chains with three copies of M2e |
COBRA H1 HA |
University of North Carolina (US), University of Georgia (US) | Recombinant proteins | Preclinical | COBRA HA vaccine coadministered intranasally with a novel adjuvant. Adjuvants include PEI-Ox-DEX hydrogel, M7-CpG, and cGAMP MPs |
COBRA HA and NA proteins |
University of Georgia (US) | Recombinant proteins | Preclinical | Multivalent COBRA (computationally optimized broadly reactive antigens) HA and NA immunogens (N1 and N2) designed to cross react with several IAV strains, adjuvanted with Advax-SMTM, a novel adjuvant comprising inulin polysaccharide and CpG55.2, a TLR9 agonist, or with c-di-AMP adjuvant. |
COBRA HA-encoding mRNA |
University of Georgia (US) | Nucleic acid-based | Preclinical | mRNA encoding H1 and H3 COBRA hemagglutinins (HA) or wild-type (WT) influenza HAs encapsulated in lipid nanoparticles (LNPs) |
COBRA-VLP |
University of Georgia (US), Cleveland Clinic (US) | Virus-like particles (VLP) | Preclinical | VLP constructs expressing COBRA (computationally optimized broadly reactive antigens) for HA or NA (specifically N2 NA); aimed at eliciting high-titer broadly cross-reactive neutralizing antibodies to multiple HA epitopes on antigenically distinct influenza viruses. Zhang 2024 (PMID: 39291424), Ge 2024 (PMID: 39079813), Nagashima 2024 (PMID: 38810648), Carlock 2023 (PMID: 37741893), Ge 2023 (PMID: 36680243), Moise 2022 (PMID: 35704783), Nunez 2021 (PMID: 34832509), Allen 2021 (PMID: 34475872), Reneer 2021 (PMID: 33692193), Allen 2021 (PMID: 33654128), Reneer 2020 (PMID: 33115871), Huang 2020 (PMID: 31852790), Nunez 2020 (PMID: 31733946), Sautto 2020 (PMID: 31811019), Ross 2019 (PMID: 30905528), Skarlupka 2019 (PMID: 31448974), Bar-Peled 2019 (PMID: 31481254), Allen 2017 (PMID: 28789850), Wong 2017 (PMID: 28978710), Carter 2017 (PMID: 28978709), Carter 2016 (PMID: 26912624), Crevar 2015 (PMID: 25671661), Giles 2012 (PMID: 22190399), Giles 2011 (PMID: 21320540), Press Release 9-20-2023, Press release 7-14-2022, Developer presentation 2023
|
CodaVax |
Codagenix (US) | Influenza virus-based | Phase 1 | LAIV generated through synthetic attenuated virus-engineering (SAVE); uses an algorithm to “de-optimize” the influenza HA and NA gene segments for reduced translation in human cells, resulting in virus attenuation while preserving the immunogenicity of wild-type virus; aimed at stimulating an immune response against influenza viruses from multiple seasons and multiple decades (e.g. influenza viruses from 1970s and 1930s). Goal |
Combinatorial polymeric nanoshell |
National Taiwan University (Taiwan) | Non-VLP nanoparticles | Preclinical | Nanoshell vaccine with co-encapsulation of peptides aimed at inducing a T cell response. |
Conjugate vaccine and P8 carrier peptide |
TRIA Bioscience (US) | Non-VLP nanoparticles | Preclinical | Nanoparticle-based peptide containing the highly conserved alpha-helical domain within the influenza HA stem (peptides modified with the Helix A epitope); GLA-SE adjuvanted and aimed at inducing functional antibodies to small molecules and protein-based epitopes. |
Conjugated HA stem |
University of Melbourne (Australia) | Recombinant proteins | Preclinical | Chemically coupled peptide derived from head domain of PR8 HA with HA stem protein. |
Conserved T cell epitope DNA vaccine |
Saint Louis University (US) | Nucleic acid-based | Preclinical | T-cell targeted DNA vaccine containing multiple pan-DR- and HLA-A2 restricted, highly conserved influenza epitopes. Status: Active |
CTA1-3M2e-DD (FPM2e) |
University of Gothenburg (Sweden), Ghent University (Belgium) | Non-VLP nanoparticles | Preclinical | Combined M2e-based fusion protein with a cholera toxin-derived adjuvant (CTA1-DD) and lipid nanoparticles; aimed at enhancing anti-M2e antibodies and CD4+ T cell responses. |
ctLAIV |
Yonsei University (South Korea) | Influenza virus-based | Preclinical | Caspase-triggered live attenuated influenza vaccine (ctLAIV), which is self-attenuated by the host caspase-dependent cleavage of internal viral proteins. |
cVLPs |
Jiaxing University (China) | Virus-like particles (VLP) | Preclinical | The conserved stalk domain and 4M2e co-anchored to the surface particles to generate chimeric influenza VLPs aimed at inducing humoral and mucosal immune responses. |
cVLPs |
University of Copenhagen (Denmark), Scripps Research Institute (US) | Virus-like particles (VLP) | Preclinical | Recombinant vaccine antigens (HAstem or rNA) displayed on the surface of rigid capsid-based virus-like particles (cVLP). (formerly: CLP-HAstem) |
CyCMV/Flu |
Oregon Health & Science University (US) | Virus-vectored | Preclinical | Cytomegalovirus (CMV)-vectored vaccine (CyCMV) expressing conserved internal influenza antigens (M1, NP, and PB1), aimed at inducing lung-resident influenza-specific CD4+ T cells to provide long-lived heterosubtypic protection. |
dbDNA-encoded NA |
Imperial College London (UK) | Nucleic acid-based | Preclinical | Influenza virus vaccines made using a closed linear DNA platform, Doggybone™ DNA (dbDNA), produced by a rapid and scalable cell-free method and encoding NA |
DCVC H1 HA mRNA-LNP |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Nucleic acid-based | Phase 1 | An mRNA encoding the full-length HA of influenza A/California/07/2009 (H1N1). Goal |
Deglycosylated modified HA |
Xiamen University (China) | Recombinant proteins | Preclinical |
Deglycosylated modified HA proteins from H3N2 with various lengths of glycans administered intramuscularly |
deltaFLU |
Vivaldi Biosciences (US) | Influenza virus-based | Phase 2 | Self-adjuvanted, nonstructural protein 1 (NS1)-deficient, replication-deficient LAIV; administered as a nasal spray; aimed at stimulating interferon, mucosal cross-neutralizing IgA antibodies, systemic cytotoxic T-cell response (Th1) and B-cell response with cross-neutralizing antibodies and memory T-cell response.
Goal Nicolodi 2019 (PMID: 31155415), Morokutti 2014 (PMID: 24560674), Mossler 2013 (PMID: 24183981), Krenn 2011 (PMID: 21490925), Wacheck 2010 (PMID: 20039806), NCT01369862 (P1/2), NCT01078701 (P2a), NCT03745274 (P1), NCT00724997 (P1), Press Release 12-18-2023, Press Release 6-5-2023, Press Release 3-29-2023, Press Release 11-29-2021, Press Release 11-23-2020, Press Release 6-19-2019, Press Release 4-4-2018, Press Release 2-12-2018, Developer website, NIH Funding
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DNA constructs with plasmids encoding conserved antigens |
State Research Center of Virology and Biotechnology (Russia) | Nucleic acid-based | Preclinical | DNA encoding artificial antigens based on the HA stalk and M2 protein to induce cross-protective humoral and cell-mediated responses. |
DNA prime-subunit protein boost |
Shanghai Institute of Biological Products (China) | Nucleic acid-based | Preclinical | DNA plasmid encoding conserved M1 (prime) and soluble recombinant M1 subunit protein (boost); aimed at inducing cellular and humoral immune responses for cross protection against heterosubtypic virus infection. |
Double-layered protein nanoparticles |
Georgia State University (US) | Non-VLP nanoparticles | Preclinical | Layered protein nanoparticles expressing multivalent conserved antigens (M2e, NP, HA stem domains); conjugated with truncated flagellin (tFliC); aimed at inducing broadly cross-protective immune responses. Status: Active Kim 2024 (PMID: 39240547), Wang 2023 (PMID: 36265560), Song 2022 (PMID: 35810540), Dong 2022 (PMID: 35084819), Dong 2022, Ma 2021 (PMID: 34743020), Wang 2021 (PMID: 34179728), Tang 2020 (PMID: 33114336), Wang 2020 (PMID: 31840437), Deng 2018 (PMID: 30065113), Deng 2018 (PMID: 30394725), Wang 2018 (PMID: 30365905), Deng 2018 (PMID: 29367723), Chang 2018 (PMID: 30092060), Deng 2017 (PMID: 28622575), Wang 2014 (PMID: 23988715), Press Release 7-1-2019, NIH Funding
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EBS-UFV-001 (UFluA) |
Emergent BioSolutions (US) | Non-VLP nanoparticles | Phase 1 | Nanoparticle based vaccine that self-assembles during production and that displays a cross-reactive HA antigen for influenza virus A groups 1 and 2. The self-assembling HA stabilized stem nanoparticle technology was developed by and licensed from NIAID. UFluA is comprised of DP-UFluA (1:1 A1-ssnp and A2-ssnp antigens) and contains aluminum hydroxide and CpG adjuvants. Goal |
EFn-3xM2e-HA2+PA |
Texas Tech University (US) | Recombinant proteins | Preclinical | Antigen consisting of 3 tandem M2e repeats plus HA2, in combination with a detoxified anthrax edema toxin (EFn plus PA); aimed at eliciting antigen-specific IgG responses; administered intranasally. |
Epigraph HA |
University of Nebraska−Lincoln (US) | Virus-vectored | Preclinical | Vaccine designed using the Epigraph vaccine antigen designer, which uses a graph-based algorithm to create vaccine antigens with maximized potential epitope coverage of a highly diverse sequence population. For example, a universal swH3 vaccine by computationally designing a cocktail of three swH3 hemagglutinins (HA), or immunogens designed against the HA protein of IBV (IBV-Epi). |
fH1/DSP-0546LP |
Sumitomo Pharma (Japan), National Institutes of Biomedical Innovation, Health and Nutrition (Japan) | Recombinant proteins | Phase 1 | Post-fusion HA antigens adjuvanted with a newly developed liposomal SA-2 containing a synthetic toll-like receptor (TLR) 7 agonist (DSP-0546) compound. Goal |
FLU-v |
ConserV Bioscience (UK), Imutex (UK) | Recombinant proteins | Phase 2 | Peptide-based construct derived from conserved regions of internal proteins (M1, IAV-NP, IBV-NP, and M2) aiming to provide a broadly protective immune response against influenza A and B through viral clearance by cytotoxic T cell responses. Goal Oftung 2022 (PMID: 36146606), Pleguezuelos 2020 (PMID: 32150750), Pleguezuelos 2020 (PMID: 32194999), Abbasi 2020 (PMID: 32286631), Van Doorn 2017 (PMID: 28376743), Pleguezuelos 2015 (PMID: 26084515), Pleguezuelos 2015 (PMID: 25994549), Pleguezuelos 2012 (PMID: 22575166), Stoloff 2007 (PMID: 17668898), Press release 3-16-2020, Press release 1-11-19, NCT02962908 / EudraCT 2015-001932-38 (P2b), NCT03180801 / EudraCT 2016-002134-74 (P2b), NCT01226758 (P1b), NCT01181336 (P1b), Developer Website: ConserV Bioscience, Developer website: Imutex, NIH Funding
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FluMos self-assembling nanoparticle |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Non-VLP nanoparticles | Phase 1 | Uses computationally designed nanoparticle immunogens that controllably display diverse HA trimers in an ordered array on self-assembling protein nanoparticles; aimed at eliciting both HAI activity and protective stem-directed neutralizing antibodies against heterosubtypic influenza viruses. (Formerly: FluMos-v1) Goal Yang 2024 (PMID: 38402303), Alabanza 2023 (PMID: 37451877), Yang 2023 (PMID: 36906406), Shajahan 2023 (PMID: 36723411), Boyoglu-Barnum 2021 (PMID: 33762730), Kanekiyo 2019 (PMID: 30742080), Krammer 2019 comment (PMID: 30742079), Georgiev 2018 (PMID: 29451984), Kanekiyo 2013 (PMID: 23698367), NCT05968989 (P1), NCT04896086 (P1), News Story 9-27-2023, Press Release 9-15-2023, Press Release 6-1-2021, Press Release 5-6-2021, NIH Funding, NIH Funding, Developer Website: NIAID
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FP-01.1 |
Immune Targeting Systems (now Altimmune) (US) | Recombinant proteins | Phase 2 | Novel construct consisting of 6 synthetic peptides linked to an inert fluorocarbon chain, encapsulating multiple conserved epitopes (NP, M, and PB1/PB2); aimed at generating T cell responses to divergent influenza strains. Goal |
G1 mHA |
Janssen Vaccines and Prevention, J&J (Netherlands) | Recombinant proteins | Phase 2 | Group 1 HA stem-based antigen, based on an approach that removes the immunodominant HA head region while stabilizing the structure of the stem region; aimed at inducing broadly neutralizing antibodies. (Formerly: Mini-HA) Goal |
GammaFlu |
Gamma Vaccines (Australia) | Influenza virus-based | Preclinical | Whole influenza virus inactivated with gamma irradiation to prevent viral replication, leaving the external and internal protein antigens intact; aimed at stimulating antibodies and cytotoxic T-cells to provide cross-protective immunity; intranasal administration. |
Glycolipid peptide |
Monash University (Australia), Victoria University of Wellington (New Zealand) | Recombinant proteins | Preclinical | Synthetic long peptides (SLP) from immunogenic MHC class I-binding CD8+ T cell epitopes covalently attached to an α-galactosylceramide adjuvant, a natural killer T cell agonist; aimed at stimulating influenza-specific memory cytotoxic T lymphocytes and cross-protective immune responses against conserved IAV epitopes. |
H1 mosaic HA |
University of Nebraska−Lincoln (US), St Jude Children’s Research Hospital (US) | Virus-vectored | Preclinical | Replication-defective Adenovirus type 5-vectored mosaic HA based on full-length H1 HA or multivalent HA consensus genes; aimed at inducing cellular and humoral immune responses against divergent influenza strains. |
H1, H3 COBRA IIV |
University of Georgia (US), Cleveland Clinic (US) | Influenza virus-based | Preclinical | Reassortant influenza viruses expressing H1 and H3 computationally optimized broadly reactive antigens (COBRA) HA antigens. Shi 2024 (PMID: 38826029), Nagashima 2024 (PMID: 38810648), Editors 2024 (PMID: 38198500), Dzimianski 2023 (PMID: 37185989), Nagashima 2023 (PMID: 36851561), Ross 2022 (PMID: 36016202), Abbadi 2022 (PMID: 35916534), Nagashima 2022 (PMID: 35697384), Allen 2022 (PMID: 35289635), Huang 2021 (PMID: 34358209), Sautto 2021 (PMID: 33853960), Sautto 2018 (PMID: 31022693), Allen 2018 (PMID: 30265682)
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H1-based cHAs |
University of Ghana (Ghana) | Recombinant proteins | Preclinical | Chimeric HAs (cHAs) generated with consensus sequence building aimed at inducing cross-reactive antibodies. |
H1c-mRNA-LNP |
National Engineering Technology Research Center for Combined Vaccines (China) | Nucleic acid-based | Preclinical | A lipid nanoparticle (LNP)-encapsulated nucleoside-modified mRNA vaccine (mRNA-LNPs) that encodes a consensus full-length HA sequence (H1c) |
H2-CON |
University of Nebraska−Lincoln (US) | Virus-vectored | Preclinical | Adenoviral-vectored centralized consensus HA construct against H2 influenza A virus, designed to induce broadly protective antibody titers when delivered in a prime-boost strategy first by Ad6 and followed with Ad5. |
H3N8 live attenuated virus vaccine |
Iowa State University (US) | Influenza virus-based | Preclinical | Live attenuated equine influenza virus (LAIV) equine H3N8 vaccine to induce broad protection without the need for non-influenza viral vectors, multiple HAs, or foreign protein scaffolds common to other universal influenza vaccine candidates. |
HA mini-stems |
University of Hong Kong (Hong Kong SAR, China) | Recombinant proteins | Preclinical | H5-based HA mini-stem protein folding as a trimer in a pre-fusion confirmation of the HA stem; uses a quarter of full length HA to focus the immune response to the conserved epitope of known broadly neutralizing antibodies in the stem domain of HA. |
HA stem protein |
National Institute of Allergy and Infectious Diseases (NIAID) (US), Indian Institute of Science (India) | Recombinant proteins | Preclinical | Novel approaches for constructing HA stem-fragment immunogens; aimed at overcoming HA head immunodominance and stimulating anti-stem germinal center B cell and antibody responses. |
HA trimers |
California Institute of Technology (US) | Non-VLP nanoparticles | Preclinical | Uses the SpyCatcher-SpyTag “plug and display” strategy to covalently couple trimeric HAs to symmetric particles with different numbers of attachments sites, resulting in mosaic particles displaying HA antigens derived from up to 8 strains of group 1 and group 2 influenza A viruses. |
HA, NP, and 3M2e mRNA |
Chinese PLA General Hospital (China) | Nucleic acid-based | Preclinical | mRNA vaccine encoding influenza hemagglutinin (HA), nucleoprotein (NP), and three tandem repeats of matrix protein 2 (3M2e). |
HA-clamp proteins |
University of Queensland (Australia) | Recombinant proteins | Preclinical | Molecular clamp which utilizes the highly stable trimerization domain to allow for efficient production and purification of conformationally stabilized perfusion hemagglutinin HA |
HA-encoding mRNA |
University of Georgia (US) | Nucleic acid-based | Preclinical | Novel quadravalent mRNA influenza vaccine encoding hemagglutinin (HA) proteins. |
HA-F DNA vaccine |
Jilin University (China) | Nucleic acid-based | Preclinical | A DNA vaccine designed by fusing influenza virus HA with self-assembled ferritin nanoparticles aimed at providing robust immunogenicity, high protective efficacy and being an effective vaccine with rapid production |
HA-liposomes |
Monash University (Australia) | Non-VLP nanoparticles | Preclinical | Production of lipid nanoparticle subunit vaccines with HA immunogens functionalized on the surface of the liposomes; uses advanced microfluidic mixing technology (NanoAssemblr) to enable rapid preparation of liposomal vaccines with increased concentrations of HA antigens on the liposome surface; aimed eliciting HA-specific B cell and follicular helper T cell immune responses. |
HA-SAV |
Yonsei University (South Korea) | Non-VLP nanoparticles | Preclinical | A self-assembled vaccine (SAV) platform comprising antigen-polymer conjugates to elicit enhanced immune responses against pathogen |
HA-T-AGM Protein |
Translational Health Science & Technology Institute (India) | Recombinant proteins | Preclinical | A recombinant full-length soluble trimeric HA protein expressed in mammalian Expi293F expression system administered intradermally and with Addavax adjuvant |
HA-VLP-Cyt |
Georgia State University (US) | Virus-like particles (VLP) | Preclinical | Cytokine-adjuvanted influenza hemagglutinin virus-like particles (HA-VLP) vaccine aimed at inducing cellular and humoral immunity |
HA/GP nanoparticles |
Georgia State University (US) | Non-VLP nanoparticles | Preclinical | Polyethyleneimine-functionalized graphene oxide nanoparticles (GP nanoparticles); administered intranasally; aimed at enhancing HA immunogenicity |
HA/M1 VLP |
Georgia State University (US) | Virus-like particles (VLP) | Preclinical | Sequential administration with heterosubtypic HA VLPs harboring H1, H8, and H13 from the HA phylogenetic group 1, or H3, H4, and H10 from the HA phylogenetic group 2, or in various combinations; aimed at eliciting broad protection against divergent viruses in the same HA phylogenetic group or both groups. |
HA2 HA-ferritin nanoparticle |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Non-VLP nanoparticles | Phase 1 | Ferritin nanoparticle vaccine composed of the ectodomain of the HA from the H2N2 pandemic strain A/Singapore/1/57 genetically fused to the ferritin subunit derived from Helicobacter pylori that displays eight antigenically intact influenza H2 HA trimers in an orderly array on the nanoparticle surface Goal |
HAd-C5-NP(H7N9) |
Purdue University (US) | Virus-vectored | Preclinical | A mucosal Ad vector-based vaccine expressing NP, from an H7N9 influenza virus, with AIP-C5, an autophagy-inducing peptide (AIP) aimed at enhancing T cell immune responses. |
HAm |
Sun Yat-sen University (China) | Recombinant proteins | Preclinical | Stabilized trimeric recombinant mosaic HA proteins named HAm, expressed using a protein-based vaccine platform |
HAsd protein |
Southwest Jiaotong University College of Medicine (China) | Recombinant proteins | Preclinical | Recombinant protein based construct targeting the HA stalk domain (HAsd) displayed on the surface of L. lactis; aimed at providing cross-immunity against divergent influenza A viruses. |
HBc VLPs |
Chinese Academy of Sciences (China) | Virus-like particles (VLP) | Preclinical | Biomimetic dual-antigen hybrid nanovaccine VLP construct with interior NP and exterior M2e antigens, using a hepatitis B virus core (HBc) VLP; aimed at inducing a cross-protective immune response. |
HBc-4M2eh (Uniflu) |
Russian Academy of Sciences (Russia), VA Pharma (Russia) | Virus-like particles (VLP) | Phase 1 | Vaccine containing 4 copies of M2e fused within the immunodominant loop of the hepatitis B virus core antigen (HBc); aimed at inducing M2e-antibody responses. (Formerly: M2e VLP) Goal |
Helix-A stem nanoparticle |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Non-VLP nanoparticles | Preclinical | Nanoparticle-based vaccine that displays multiple copies of the conserved influenza helix-A region per nanoparticle subunit |
Hexaplex liposomes |
State University of New York at Buffalo (US) | Non-VLP nanoparticles | Preclinical | Recombinant HA and NA multimeric proteins derived from three influenza serotypes, H1N1, H3N2, and type B, are surface displayed on nanoliposomes co-loaded with immunostimulatory adjuvants, generating "hexaplex" particles |
hlHA IIV |
Duke University (US) | Influenza virus-based | Preclinical | Authentic influenza A virus (IAV) particles that harbor “headless” HA (hlHA) along with the normal complement of other viral proteins to serve as an inactivated influenza vaccine (IIV) |
Hybrid fusion protein combination vaccine |
Emory University (US), Georgia State University (US) | Virus-like particles (VLP) | Preclinical | Combination influenza and SARS-CoV-2 (COVID-19) VLP vaccine that uses influenza virus-like particles (VLP) incorporated by protein transfer with glycosylphosphatidylinositol (GPI)-anchored SARS-CoV-2 RBD fused to GM-CSF as an adjuvant |
IA-SNBs |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Non-VLP nanoparticles | Preclinical | HA complexes arranged as lipid discs with multiple trimeric HAs displayed along the perimeter, termed spike nanobicelles (SNB), used to synthesize in vitro assembled spiked nanobicelles (IA-SNB) from a classical 1934 H1N1 influenza virus. |
IAV-nanovax |
University of Iowa (US), Iowa State University (US) | Non-VLP nanoparticles | Preclinical | Combination nanovaccine platform based on pentablock copolymer micelles and polyanhydride nanoparticles, incorporating the hemagglutinin (HA) and nucleoprotein (NP) antigens from H1N1; aimed at boosting cell-mediated immune responses. Status: Active |
Intranasal NLP:NP |
University of Rochester Medical Center (US) | Non-VLP nanoparticles | Preclinical | Self-assembling nanolipoprotein particle linked to NP with an adjuvant |
Inverted HA VLP |
Georgia Institute of Technology (US), Icahn School of Medicine at Mount Sinai (US) | Virus-like particles (VLP) | Preclinical | A VLP that displays multiple copies of an antigen binding fragment (Fab) which recognizes the apex of the HA head causing the subsequent binding of HA to result in its presentation in an inverted orientation. |
ISCOMs/MPLA-adjuvanted SDAD protein nanoparticles |
Georgia State University (US) | Non-VLP nanoparticles | Preclinical | A core/shell protein nanoparticle consisting of influenza nucleoprotein (NP) as the core and NA1-M2e or NA2-M2e fusion proteins as the coating antigens by SDAD hetero-bifunctional crosslinking boosted by immune-stimulating complexes (ISCOMs)/monophosphoryl lipid A (MPLA) adjuvants |
LAIV+4M2e |
Institute of Experimental Medicine (Russia) | Influenza virus-based | Preclinical | Recombinant LAIV expressing additional 4 M2e tandem repeats (4M2e); aimed at enhancing M2e-mediated cross-protection against heterologous viruses. |
LHNVD-105 |
Longhorn Vaccines and Diagnostics (US) | Recombinant proteins | Preclinical | Multi-epitope unconjugated and CRM-conjugated peptides targeting HA, NA and M2e; formulated with ALFQ (Army liposomal) adjuvant |
Liposomal peptide vaccine |
Griffith University (Australia) | Non-VLP nanoparticles | Preclinical | Liposomal vaccine adjuvanted with the TLR4 agonist, 3D-PHAD, and express the conserved influenza A M2e epitope |
m-cNA-M2e VLP |
Georgia State University (US) | Virus-like particles (VLP) | Preclinical | A single entity of VLP displaying consensus multi-neuraminidase (NA) subtypes (cN1, cN2, BcNA) and M2 ectodomain (M2e) tandem repeat (mcNA-M2e VLP) administered intramuscularly. |
M2e based recombinant fusion proteins |
Russian Ministry of Health (Russia) | Recombinant proteins | Preclinical | Recombinant plant-produced protein (Flg4M2eHA2-1) based on the combination of 4 tandem copies of M2e and conserved fragments of HA2, fused to bacterial flagellin containing CD8+ epitopes of NP as an adjuvant for mucosal immunization; administered intranasally. |
M2e Nanoclusters |
Texas Tech University (US), Georgia State University (US) | Non-VLP nanoparticles | Preclinical | Unadjuvanted cross linked M2e nanoclusters (NCs) Status: Active |
M2e VLP MP |
Mercer University (US) | Virus-like particles (VLP) | Preclinical | Adjuvanted M2e based VLP encapsulated into a micro particulate matrix |
M2e-based self-assembled nanoparticle |
Fudan University (China) | Non-VLP nanoparticles | Preclinical | M2e epitope-bearing self-assembling nanoparticles that aim to induce antibodies against M2e on different influenza subtypes. |
M2e-based VLPs (ACAM-FluA) |
Ghent University (Belgium), Sanofi Pasteur (France) | Virus-like particles (VLP) | Phase 1 | M2e-based VLP constructs; aimed at inducing cross-reactive CD8+ T cell responses. Goal |
M2e-CRM197 conjugates |
Chinese Academy of Sciences (China) | Recombinant proteins | Preclinical | Dual-site specific conjugation of M2e peptide with the CRM197 carrier protein under denaturation. |
M2e-H3 stalk |
Georgia State University (US) | Recombinant proteins | Preclinical | Chimeric M2e and H3 hemagglutinin (HA) stalk protein vaccine engineered by genetically linking M2e repeat to the engineered H3 stalk domain with stabilizing HA1 N- and C-terminal region and point mutations |
M2e/CpG-ODN/TMC |
Agricultural Research, Education and Extension Organization (Iran) | Non-VLP nanoparticles | Preclinical | Nasal vaccination with the M2e/CpG-ODN antigen encapsulated in N-Trimethyl Chitosan (TMC) nanoparticles |
M2e5x VLP (multiple approaches) |
Georgia State University (US), Kyung Hee University (S Korea) | Virus-like particles (VLP) | Preclinical | Conserved tandem repeat M2e5x VLPs alone or in combination with other technologies, including: HA VLPs, flagellin VLPs, IIV by microneedle patch, and intranasal administration; aimed at inducing heterosubtypic cross protective immunity. |
M2SR |
FluGen (US) | Influenza virus-based | Phase 2 | Novel single-replication (SR) platform for influenza A or B virus based on an otherwise wild-type influenza virus that does not express the M2 ion channel protein (M2-deficient); administered intranasally; aimed at eliciting cross-reactive antibodies against conserved HA stem and systemic and mucosal immune responses that block virus replication in the lung and provide cross-lineage protection against influenza virus. Quad M2SR, a quadrivalent form of this vaccine candidate, is currently in preclinical development.
Goal Hill-Batorski 2024 (PMID: 39012796), Sambhara 2024 (PMID: 39004095), Eiden 2024 (PMID: 39004096), Hill-Batorski 2023 (PMID: 37112710), Eiden 2023 (PMID: 36350017), Sarwar 2022 (PMID: 36560540), Eiden 2022 (PMID: 34323977), Eiden 2021, Moser 2019 (PMID: 31280945), Hatta 2018 (PMID: 30007825), Hatta 2017 (PMID: 28668565), Sarawar 2016 (PMID: 27595896), Hatta 2011 (PMID: 21272601), Watanabe 2009 (PMID: 19321619), News story 8-15-2024, Press Release 7-12-2024, News story 10-3-2022, Press release 11-9-2022, Press release 9-7-2022, Press Release 8-1-2022, Press Release 7-27-2022, Press release 6-22-2022, Press release 8-2-2021, Press Release 7-1-2021, Press release 5-25-2021, Press Release 8-28-2019, EudraCT 2017-004971-30 (P2a), NCT04960397 (P1b), NCT05163847 (P1b), NCT04785794 (P1b), NCT03553940 (P1), NCT03999554 (P1), NCT02822105 (P1), Developer website
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MAV-1 HA |
University of Liège (Belgium) | Virus-vectored | Preclinical | Recombinant mouse adenovirus (AdV) type 1 (MAV-1) expressing the HA of PR8, administered orally |
mHAs |
Chinese Academy of Sciences (China) | Nucleic acid-based | Preclinical | mRNA vaccine (mHAs) encoding the HA stem antigen of the influenza A (H1N1) virus. |
Micro-consensus DNA vaccine |
Wistar Institute (US), Inovio Pharmaceuticals (US) | Nucleic acid-based | Phase 1 | Synthetic microconsensus DNA platform based on 4 plasmid-encoding microconsensus H1 and H3 HA antigens, each containing a limited consensus sequence based on analysis of a subset of primary sequences of H1 and H3 HA antigens; aimed at inducing protective levels of HAI titers to diverse isolates of H1N1 and H3N2 influenza; delivered by intradermal/intramuscular electroporation (EP); aimed at eliciting antibody and T-cell responses. Goal Xu 2020 (PMID: 32328416), Yan 2018 (PMID: 29100705), Elliott 2018 (PMID: 30062926), Yan 2014 (PMID: 24631084), Kichaev 2013 (PMID: 23954979), NCT01587131 (P1), NCT01405885 (P1), NCT01403155 (P1), NCT01184976 (P1), NCT01142362 (P1), Developer website: Wistar Institute, Developer website: Inovio Pharmaceuticals
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Mini-HA-LS Nano-vaccine |
Huazhong Agricultural University (China) | Non-VLP nanoparticles | Preclinical | Mini-HA proteins expressed on lumazine synthase (LS) nanoparticles by SpyTag/SpyCatcher aimed at eliciting potent immune responses |
MLN-mRNA |
Shanghai Institute of Biological Products (China) | Nucleic acid-based | Preclinical | A novel mRNA-based multiantigen influenza vaccine based on a single mRNA molecule with a tandem of three conserved antigens of influenza A virus, including the ectodomain of the M2 ion channel (M2e), the long alpha helix of haemagglutinin stalk region (LAH), and nucleoprotein (NP) |
Modified mRNA vaccine |
Pfizer (US) | Nucleic acid-based | Phase 3 | Next generation mRNA seasonal influenza vaccine encoding WHO recommended strain Goal Hauguel 2024, Dolgin 2021 (PMID: 34635829), Abbasi 2021 (PMID: 34751730), Press Release 8-16-2024, Press Release 10-31-2023, Press Release 9-14-2022, Press Release 9-14-2022, Press Release 9-27-2021, Press Release 8-16-2018, NCT05540522 (P3), NCT06436703 (P1/2), ISRCTN13559330 (P2a), ISRCTN13789612 (P2a), NCT05052697 (P1/2), Pfizer Second Quarter 2022 Earnings Teleconference, Developer website: Pfizer
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modRNA-based combination |
Pfizer (US), BioNTech (Germany) | Nucleic acid-based | Phase 3 | Combination mRNA SARS-CoV-2 (COVID-19) and influenza vaccine containing mRNA strains encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5 subvariants as well as mRNA strands encoding the hemagglutinin of four different influenza strains Goal |
Monovalent rNA |
Sanofi (Canada) | Recombinant proteins | Preclinical | A rNA monovalent protein vaccine candidate vaccine that uses tetramer conformation to enable stability for at least 24-months at refrigerated (5°C) storage. |
Mosaic and Chimeric HA |
Icahn School of Medicine at Mount Sinai (US) | Recombinant proteins | Preclinical | Novel constructs of recombinant mosaic and chimeric HA, expressed as soluble trimeric proteins; aimed at inducing broadly protective immune responses to influenza A and B strains. |
Mosaic HA-based whole inactivated virus |
Icahn School of Medicine at Mount Sinai (US) | Influenza virus-based | Preclinical | Activated influenza B viruses displaying mosaic HA (mHA) proteins to redirect the immune response towards the immuno-subdominant conserved epitopes of the HA. |
Mosaic NA1 (mNA1) |
Sun Yat-sen University (China) | Nucleic acid-based | Preclinical | A series of genetic algorithm-based mosaic NA1 (mNA1) designed, then cloned into recombinant DNA and replication-defective Vesicular Stomatitis Virus (VSV) vector |
Mosaic VLPs |
Sun Yat-sen University (China) | Virus-like particles (VLP) | Preclinical | An HA and NA mosaic immunogen cocktail containing the majority of potential T-cell epitopes of human seasonal influenza viruses (H1N1 and H3N2) expressed as virus-like particles (VLPs) |
mRNA constructs |
Sanofi Pasteur (France) | Nucleic acid-based | Phase 2 | Monovalent and quadrivalent mRNA vaccine constructs; two candidates differing only in the LNP containing the mRNA Formerly: mRNA NA Goal |
mRNA LNP prime and intranasal PHC boost |
Georgia State University (US) | Nucleic acid-based | Preclinical | Heterologous sequential mRNA LNP priming followed by intranasal protein nanoparticle boosting immunization to confer optimal cross-protection against antigenically drifted and shifted influenza strains. See also Georgia State University’s, HA/GP nanoparticles and cGAMP-adjuvanted multivalent mRNA vaccines |
mRNA-1010 |
Moderna (US) | Nucleic acid-based | Phase 3 | Modified mRNA-based lipid nanoparticle vaccine candidate mRNA-1010 (in phase 3), a quadrivalent formulation with HA antigens from four seasonal influenza strains (A/H1N1, A/H3N2, and B/Yamagata- and B/Victoria-lineages) Goal Matz 2024 (PMID: 39416092), Lee 2023 (PMID: 37336877), Bahl 2022 , Dolgin 2021 (PMID: 34635829), Feldman 2019 (PMID: 31079849), Bahl 2017 (PMID: 28457665), Liang 2017 (PMID: 28958578), Lindgren 2017 (PMID: 29181005), NCT06602024 (P3), NCT05827978 (P3), NCT05566639 / EudraCT 2022-001638-12 (P3), NCT05415462 (P3), NCT05606965 (P2), NCT05868382 (P2), NCT05397223 (P1), NCT04956575 (P1), NCT03076385 (P1), NCT03345043 (P1), Developer website, Press release 8-1-2024, Press Release 5-2-2024, Press Release 3-27-2024, Press Release 1-8-2024, Press Release 9-13-2023, Press Release 8-3-2023, Press Release 5-4-2023, Press Release 4-11-2023, Press Release 2-16-2023, Press Release 9-8-2022, Press Release 6-7-2022, Press Release 3-24-2022, Press Release 12-10-2021, Press Release 7-7-2021, Moderna Presentation Sep 2024, Moderna Presentation Jan 2024, Moderna Presentation 2022
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mRNA-1011 and mRNA-1012 |
Moderna (US) | Nucleic acid-based | Phase 2 | Modified mRNA lipid nanoparticles mRNA-1011/1012 which are seasonal penta-/hexa-valent vaccine candidates that includes more HA antigens (e.g. H3, H1) to expand strain matching Goal Hsu 2024 (PMID: 39245055), Bahl 2022, Feldman 2019 (PMID: 31079849), Bahl 2017 (PMID: 28457665), Liang 2017 (PMID: 28958578), Lindgren 2017 (PMID: 29181005), Press Release 9-13-2023, Press Release 4-11-2023, Press Release 2-16-2023 , Press Release 3-24-2022, Press Release 12-10-2021 , NCT05827068 (P1/2), Developer Website
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mRNA-1020 and mRNA-1030 |
Moderna (US) | Nucleic acid-based | Phase 2 | Modified mRNA lipid nanoparticles mRNA-1020 and mRNA-1030 which incorporate HA and NA antigens to target more conserved regions of the virus Goal Bahl 2022 , Dolgin 2021 (PMID: 34635829), Feldman 2019 (PMID: 31079849), Bahl 2017 (PMID: 28457665), Liang 2017 (PMID: 28958578), Lindgren 2017 (PMID: 29181005), NCT05333289 (P1/2), Developer website, Press Release 9-13-2023, Press Release 4-11-2023, Press Release 2-16-2023, Press Release 4-11-2022, Press Release 3-24-2022, Press Release 12-10-2021
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mRNA-1083 |
Moderna (US) | Nucleic acid-based | Phase 3 | Combination SARS-CoV-2 (COVID-19) and influenza vaccine. Single dose mRNA vaccine encoding for the COVID-19 spike protein and flu HA glycoproteins of 4 flu strains. mRNA-1083 comprises components of mRNA-1010, Moderna's next-generation vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. (Formerly: mRNA-1073 and mRNA-1083) Goal NCT06097273 (P3), NCT06508320 (P2), NCT05827926 (P1/2), NCT05375838 (P1/2), Press release 8-1-2024, Press Release 6-10-2024, Press Release 5-2-2024, Press Release 3-27-2024, Press Release 1-8-2024, News Story 10-26-2023, Press Release 10-24-2023, Press release 10-4-2023, Press Release 9-13-2023, Press Release 5-4-2023, Press Release 4-11-2023, Press Release 2-16-2023, Press Release 9-8-2022, Press Release 6-7-2022, Press Release 3-24-2022, Press Release 12-10-2021, News Story 9-10-2021, Press Release 9-9-2021, Moderna Presentation Sep 2024, Moderna Presentation Jan 2024, Moderna Presentation Nov 2021, Developer Website: Moderna
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mRNA-1230 |
Moderna (US) | Nucleic acid-based | Phase 1 | Multi-component mRNA SARS-CoV-2 (COVID-19), influenza and respiratory syncytial virus (RSV) vaccine administered intramuscularly. Goal |
mRNA-Flu |
National Institute for Public Health and the Environment (Netherlands) | Nucleic acid-based | Preclinical | Nucleoside-modified mRNA-LNP encoding three conserved internal proteins of H1N1 influenza virus, NP, M1, and PB1 |
mRNA-LNP |
University of Pennsylvania (US), Icahn School of Medicine at Mount Sinai (US) | Nucleic acid-based | Preclinical | Nucleoside modified mRNA vaccine constructs encoding either conserved antigens, or hemagglutinin antigens from all 20 known influenza A and B virus subtypes aimed at inducing antigen-specific cellular and humoral immune responses to protect against diverse influenza virus strains. Kirby 2023 (PMID: 36708722), Villanueva 2023 (PMID: 36631700), Gouma 2022 (PMID: 36533954), Pecetta 2022, O'Leary 2022 (PMID: 36450841), Kelvin 2022 (PMID: 36423290), Arevalo 2022 (PMID: 36423275), McMahon 2022 (PMID: 36322769), Pardi 2022 (PMID: 35945226), Muramatsu 2022 (PMID: 35131437), Alameh 2021, Freyn 2021 (PMID: 34485597), Willis 2020 (PMID: 31915303), Freyn 2020 (PMID: 32359470), Pardi 2018 (PMID: 30135514), Limberis 2013 (PMID: 23720583), News Story 2023, Press Release 12-6-2022, Press Release 12-6-2022, Press Release 11-25-2022, NIH Funding, NIH Funding
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mRNA/LNP vaccine |
Merck & Co. (US) | Nucleic acid-based | Preclinical | LNP-encapsulated chemically modified mRNA vaccines encoding various forms of influenza antigens |
Multi-antigen DNA vaccine |
University of Washington (US) | Nucleic acid-based | Preclinical | Adjuvanted multi-antigen DNA vaccine consisting of HA, M2, and NP antigens, administered in 3 sequential doses; aimed at inducing mucosal responses and cross-reactive T cell responses. |
Multi-epitope mRNA-based vaccines (MH, MH-T, and MH-TF) |
Key Laboratory of Jilin Province for Zoonosis Prevention and Control (China) | Nucleic acid-based | Preclinical | Self-assembled mRNA-based multi-epitope influenza vaccine, which combines three conserved antigens derived from the influenza A virus (M2 ion channel’s extracellular domain (M2e), the conserved epitope of located in HA2 of hemagglutinin (H1, H3, B), and HA1 of hemagglutinin) |
Multimeric-001 (M-001) |
BiondVax Pharmaceuticals (Israel) | Recombinant proteins | Phase 3 | A single recombinant protein of 9 conserved M1, NP, and HA epitopes; aimed at inducing T cell responses and enhanced B-cell responses to circulating and novel strains. Goal Atmar 2023 (PMID: 36941155), Phillipson 2019 (PMID: 35174313), Lowell 2017 (PMID: 28065476), Van Doorn 2017 (PMID: 28296763), Astmon 2014 (PMID: 25173483), Gottlieb 2014 (PMID: 25172355), Astmon 2012 (PMID: 22318394), NCT03450915 (P3), NCT03058692 (P2), NCT02691130 (P2b), NCT02293317 (P2), NCT01419925 (P2), NCT01146119 (P2), NCT01010737 (P1/2), NCT00877448 (P1/2), Press Release 10-23-2020, Developer website: Now known as Scinai Immunotherapeutics
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Multiple HA-DNA |
University of Oslo (Norway) | Nucleic acid-based | Preclinical | DNA-encoded vaccine proteins targeting APCs; uses either the ectodomain of NA as an antigen, or HA genes from 16 different HAs representing nearly all of the different HA subtypes (except H1 and H7) and inserts them into a DNA vaccine format; aimed at inducing NA immunity and delivery of the HA protein antigens to MHC class II molecules on APCs. |
Multivalent DNA nanovaccine |
Taizhou University (China) | Non-VLP nanoparticles | Preclinical | pβH7N2SH9/DGL NPs developed by encapsulating the pβH7N2SH9 within the dendrigraft poly-l-lysines nanoparticles |
Multivalent Modified mRNA |
GSK (UK), CureVac (Germany) | Nucleic acid-based | Phase 2 | An mRNA-based modified, multivalent construct including the 4 WHO recommended influenza strain antigens. Goal Lutz 2017 (PMID: 29263884), Kallen 2013 (PMID: 23921513), Petsch 2012 (PMID: 23159882), NCT06431607 (P2a), NCT05823974 (P1/2), NCT05252338 (P1), Press Release 11-12-2024, Press Release 9-12-2024, News story 9-12-2024, Press Release 7-3-2024, Press Release 4-4-2024, Press Release 11-1-2023, Press Release 9-12-2023, Press Release 5-8-2023, Press Release 4-25-2023, Press Release 1-30-2023, Press Release 2-10-2022, GSK presentation 2024, GSK Presentation 2023, Developer website: GSK, Developer website: CureVac
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MVA-NP |
German Center of Infection Research (DZIF) (Germany) | Virus-vectored | Preclinical | Recombinant MVA candidate vaccines that deliver the highly conserved internal nucleoprotein (NP) of IAV under the transcriptional control of five newly designed chimeric poxviral promoters to further increase the immunogenic properties of the recombinant viruses (MVA-NP) |
MVA-NP+M1 (VTP-100) |
Barinthus Biotherapeutics (UK) | Virus-vectored | Phase 2 | Modified vaccinia Ankara (MVA)–vectored construct expressing nucleoprotein (NP) and M1 protein (MVA-NP+M1); targets T cell responses to the nucleoprotein and matrix 1 core proteins of the influenza virus; co-administered with licensed quadrivalent inactivated influenza virus vaccine. Goal Evans 2024 (PMID: 38729196), Evans 2022 (PMID: 35305317), Valkenburg 2022 (PMID: 35305315), Butler 2021 (PMID: 34451976), Puksuriwong 2020 (PMID: 31740938), Swayze 2019 (PMID: 32089822), Folegatti 2019 (PMID: 30909516), Mullin 2016 (PMID: 26902548), Antrobus 2014 (PMID: 23831594), Mullarkey 2013 (PMID: 23589155), Powell 2013 (PMID: 23658773), Lillie 2012 (PMID: 22441650), Antrobus 2012 (PMID: 23118984), Berthoud 2011 (PMID: 21148512), Press Release 1-31-2020, Press Release 11-25-2019, NCT03883113 (P2), NCT03880474 (P2b), NCT03300362 (P2b), NCT00993083 (P2a), NCT03277456 (P1), NCT02014168 (P1), NCT01465035 (P1), NCT00942071 (P1), Developer website: formerly known as Vaccitech
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MVA-vectored vaccines |
Emergent BioSolutions (US) | Virus-vectored | Preclinical | MVA-vectored vaccines expressing HA, NP, M1, M2, repeats of M2e or as tandem repeats (METR), and M2e with transmembrane region and cytoplasmic loop (M2eTML) as single antigens that were delivered separately or in combination. |
N1 VLP |
Georgia State University (US), Health Canada (Canada) | Virus-like particles (VLP) | Preclinical | VLP containing NA from 2009 pH1N1; aimed at inducing cross-reactive NA inhibition activity as a component of a broadly protective vaccine. |
N1-I COBRA NA antigen |
University of Georgia (US) | Recombinant proteins | Preclinical | COBRA (computationally optimized broadly reactive antigens) generated N1-I NA vaccine designed to cross react with avian, swine and human influenza viruses of N1 NA subtype. |
N2-MPP |
Icahn School of Medicine at Mount Sinai (US) | Recombinant proteins | Preclinical | Recombinant influenza virus N1 neuraminidase vaccine candidate, N1-MPP, adjuvanted with CpG 1018, a TLR9 agonist, designed to contribute to the development of a broadly protective NA-based influenza virus vaccine candidate. Formerly N1-MPP and rNA. Hoxie 2024 (PMID: 39241354), McMahon 2023 (PMID: 37800945), Momont 2023 (PMID: 37258672), Strohmeier 2022 (PMID: 35869085), Roubidoux 2022 (PMID: 35446141), Tan 2022 (PMID: 34669506), Rajendran 2021 (PMID: 34451971), Oh 2021 (PMID: 34890255), Strohmeier 2021 (PMID: 34809451), Strohmeier 2021 (PMID: 33921722), McMahon 2020 (PMID: 32943267), McMahon 2019 (PMID: 31113896), Wohlbold 2015 (PMID: 25759506)
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N2-VLPs |
University of Natural Resources and Life Sciences Vienna (BOKU) (Austria) | Virus-like particles (VLP) | Preclinical | VLPs generated in insect cells, that are based on self-assembly and budding of the human immunodeficiency virus 1 (HIV-1) gag protein, and display N2 NA on their surface |
NA-F2A-HA mRNA-LNP |
Duke University (US) | Nucleic acid-based | Preclinical | An mRNA vaccine platform that delivers NA and HA as a single open reading frame (ORF) to enable expression of multiple unmodified antigens from a single mRNA, using a unique glycoprotein organization with an artificial furin cleavage site and 2A ribosome-skipping sequences. |
NA-Mi3 nanoparticles |
Utrecht University (Netherlands), Ghent University (Belgium) | Non-VLP nanoparticles | Preclinical | Soluble tetrameric NA antigens of the N1 and N2 subtypes conjugated to Mi3 self-assembling protein nanoparticles using the SpyTag-SpyCatcher system. |
NA-targeting circRNA vaccine |
Sun Yat-sen University (China) | Nucleic acid-based | Preclinical | Circular RNA (circRNA) vaccines containing N1, N2, and influenza B virus NA antigens to elicit broad-spectrum NA immunity against heterologous influenza |
NA-VLPs |
King Mongkut's University of Technology Thonburi (Thailand) | Virus-like particles (VLP) | Preclinical | Recombinant NA protein synthesized and assembled into VLPs, aimed at inducing anti-NA antibodies |
NA2 VLP |
Auburn University (US), Emory-UGA CEIRS (US) | Virus-like particles (VLP) | Preclinical | Vaccine containing the NA protein from A/Perth/16/2009 (H3N2) and the matrix 1 (M1) protein from A/MI/73/2015, formulated with a water-in-oil-in-water adjuvant |
NAe-HA and M2e-HA |
Georgia State University (US) | Influenza virus-based | Preclinical | Inactivated, replication-competent recombinant influenza virus expressing chimeric HA molecules with a conserved NA epitope (NAe) or conserved matrix protein (M2e) or chimeric 4xM2e-HA fusion proteins with 4M2e epitopes inserted into the H3 HA N-terminus; aimed at inducing antibody responses to conserved epitopes for heterosubtypic immunity. |
Nano-Flu (qNIV) |
Novavax (US), Emergent BioSolutions (US) | Non-VLP nanoparticles | Phase 3 | Recombinant Spodoptera frugiperda (Sf9) insect cell or baculovirus system-derived, quadrivalent haemagglutinin nanoparticle influenza vaccine (qNIV), formulated with a saponin-based adjuvant, Matrix-M™. Goal Shinde 2022, Isakova-Sivak 2022 (PMID: 34563276), Abbasi 2021 (PMID: 34751731), Shinde 2021 (PMID: 33146720), Portnoff 2020 (PMID: 32098409), Shinde 2018 (PMID: 29897849), Smith 2017 (PMID: 28844407), NCT04120194 (P3), NCT03658629 (P2), NCT03293498 (P1/2), Press Release 11-11-2024, Press Release 10-16-2024, Press Release 8-8-2024, Press Release 5-9-2023, Press Release 9-23-2021, Press Release 5-10-2021, Press Release 10-13-2020, Press Release 5-6-2020, Press Release 3-24-2020, Press Release 2-25-2020, Press Release 1-15-2020, News Story 5-9-2023, Developer website: Novavax, Developer website: Emergent BioSolutions
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NasoVAX |
Altimmune (US) | Virus-vectored | Phase 2 | Replication-deficient adenovirus serotype 5 construct designed to express influenza HA (H1) in nasal epithelial cells; administered as a nasal spray. Goal |
NM2e@DDAB/PLA nanovaccine |
Chinese Academy of Sciences (China) | Non-VLP nanoparticles | Preclinical | Fusion protein expressing the extracellular domain of matrix 2 (M2e) and nucleoprotein, NM2e, adjuvanted with a cationic solid lipid nanoadjuvant fabricated using poly(lactic acid) (PLA) and dimethyl-dioctadecyl-ammonium bromide (DDAB), to generate an NM2e@DDAB/PLA nanovaccine (Nv). |
nM2Pr |
Korea Research Institute of Bioscience and Biotechnology (Korea) | Recombinant proteins | Preclinical | Linear peptide constructs based on the N-terminal sequence of M2e (nM2e) and a helper T-cell epitope. |
NMHC |
Chinese Academy of Sciences (China) | Recombinant proteins | Preclinical | Recombinant protein, NMHC, consisting of viral conserved epitopes and a superantigen fragment |
NP mRNA |
Ghent University (Belgium) | Nucleic acid-based | Preclinical | mRNA construct encoding NP; administered intranodally; aimed at inducing systemic T cell responses and protecting against heterologous infection. |
NvC-M2ex3 |
Universiti Putra Malaysia (Malaysia) | Virus-like particles (VLP) | Preclinical | M2e antigen displayed on a chimeric protein (NvC-M2ex3) VLPs. |
Optimized M2e DNA vaccines |
Chinese Academy of Sciences (China) | Nucleic acid-based | Preclinical | Uses N-terminal extracellular region of the influenza virus M2 protein (M2e) as the target antigen; constructed two optimized M2e DNA vaccines (p-tPA-p3M2e and p-p3M2e) with increased antigenic epitope density and enhanced antigen secretion. |
OVX836 |
Osivax (France and Belgium) | Non-VLP nanoparticles | Phase 2 | Self-assembling nanoparticle with multiple copies of full-length NP antigens; aimed at stimulating antibodies, cytotoxic T cells, and T helper cells. Goal Isakova-Sivak 2023 (PMID: 37517421), Leroux-Roels 2023 (PMID: 37517422), Withanage 2022 (PMID: 34653245), Leroux-Roels 2022 (PMID: 35464450), Del Campo 2021 (PMID: 34177921), Horizon 2020, Del Campo 2019 (PMID: 30701093), NCT06582277 (P2a), NCT05569239 (P2b), NCT05734040 (P2a), NCT05284799 (P2a), NCT05060887 / EudraCT 2021-002535-39 (P2a), NCT04192500 (P2a), NCT05184387 (Observational), NCT03594890 (P1), Press Release 11-14-2024, Press Release 9-10-2024, Press Release 3-26-2024, Press Release 12-5-2023, Press Release 7-28-2023, Press Release 6-15-2023, Press Release 3-28-2023, Press Release 12-21-2022, Press Release 9-1-2022, Press Release 6-23-2022, Press Release 5-25-2022, Press Release 5-17-2022, Press Release 4-21-2022, Press release 12-2-2021, Press release 9-10-2020, Press release 7-8-2020, Press release 4-9-2020, Press Release 1-21-2020, Press release 12-5-2019, Development update 12-5-2019, Developer website, European Commission Funding
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P22-HAhead VLP |
Indiana University (US) | Virus-like particles (VLP) | Preclinical | Using SpyTag/SpyCatcher covalent attachment strategy, conjugates bacteriophage P22 VLPs with multiple copies of the HA head domain in a high-density display of multivalent antigens; aimed at conferring a potent antibody response in a rapid, scalable production system (e.g., for use in outbreak situations). |
pABOL-formulated saRNA vaccine |
Imperial College London (UK) | Nucleic acid-based | Preclinical | Bioreducible cationic polymer, pABOL used for the delivery of a self-amplifying RNA (saRNA) vaccine expressing either haemagglutinin (HA) from H1N1 or H3N2 influenza virus in a prime boost regime |
PAPB1M1 and NPPB2M2 composite immunogens in a DNA prime/viral vector boost strategy |
Shanghai Public Health Clinical Center (China) | Nucleic acid-based | Preclinical | Two novel composite immunogens containing highly conserved T-cell epitopes of 6 influenza A virus internal antigens (based on consensus amino acid sequences of M1, M2, NP, PA, PB1, and PB2 from approximately 40,000 influenza A virus strains) cloned into 3 sequential constructs; DNA prime vaccine followed by consecutive boosting with intranasal AdC68 viral vector and intramuscular Tiantan vaccinia (TTV) virus vector. |
PapMV-sM2e nanoparticles |
Laval University (Canada) | Non-VLP nanoparticles | Preclinical |
Two types of PapMV (papaya mosaic virus) nanoparticles harboring the M2e and NP antigens; aimed at inducing broadly protective immune responses. |
pEx 4M2e |
Slovak Academy of Science (Slovak Republic) | Nucleic acid-based | Preclinical | DNA vaccine aimed at inducing an anti-M2e immune response by inserting the sequence for truncated NS1 protein followed by 4xM2e into the expression vector pEx (PTriEx-4). |
pH-responsive NP vaccine |
Vanderbilt University (US) | Non-VLP nanoparticles | Preclinical | pH-responsive polymeric nanoparticle vaccine for generating antigen-specific CD8+ TRM cells in the lungs; administered intranasally; aimed at eliciting rapid generation of protective CD8+ TRM cells in the lungs. |
PIV5-NA |
University of Georgia (US) | Virus-vectored | Preclinical | Parainfluenza virus 5 recombinant vaccine candidate expressing NA (PIV5-NA) from a pandemic influenza (pdmH1N1) virus or highly pathogenic avian influenza (H5N1) virus; aimed at eliciting robust, cross-reactive protection. |
PLGA nanoparticles |
Sunway University (Malaysia) | Non-VLP nanoparticles | Preclinical | Self-adjuvanting PLGA nanoparticles encapsulating six conserved peptides |
Polyvalent DNA vaccine |
Statens Serum Institut (Denmark) | Nucleic acid-based | Preclinical | Needle-free intradermal application of a broadly protective polyvalent influenza A DNA vaccine encoding HA and NA proteins derived from less glycosylated pandemic H1N1 (2009) and H3N2 (1968) virus strains and nucleoprotein (NP) and matrix proteins (M1 and M2) from a different pandemic H1N1 (1918) strain. |
Prime and HA |
Yale University (US) | Recombinant proteins | Preclinical | Intranasal recombinant HA protein booster; used following intramuscular HA-encoding mRNA-LNP prime vaccine to elicit protective mucosal immune responses and confer sterilizing immunity against influenza virus infection. |
PROTAC |
Chinese Academy of Sciences (China) | Influenza virus-based | Preclinical | Proteolysis-targeting chimeric (PROTAC) vaccine technology that uses the host cellular ubiquitin-proteasome system to conditionally degrade influenza viral proteins that aims to elicit robust and broad humoral, mucosal and cellular immune responses against homologous and heterologous viral challenges |
Quadrivalent HA mRNA |
Greenlight Biosciences (US) | Nucleic acid-based | Preclinical | Quadrivalent mRNA vaccine encoding HA from four seasonal influenza viruses |
Quadrivalent VLP (QVLP) |
Medicago (Canada) | Virus-like particles (VLP) | Phase 3 | Nicotiana benthamiana plant-derived (Proficia®) HA-bearing quadrivalent virus-like particle (QVLP); aimed at stimulating antibody and cellular immune responses. Goal Alvarez 2022 (PMID: 35750356), Hendin 2022 (PMID: 35410323), Ward 2021 (PMID: 33581920), Ward 2020 (PMID: 33065035), Tregoning 2020 (PMID: 33065033), Pillet 2019 (PMID: 31166987), Won 2018 (PMID: 30448064), Pillet 2016 (PMID: 26987887), Press Release 2-3-2023, Press Release 10-1-2019, Press Release 06-2018, NCT03739112 / EudraCT 2018-001894-26 (P3), NCT03301051 / EudraCT 2017-001239-38 (P3), NCT03321968 (P3), NCT04622592 (P1/2), NCT02831751 (P2), NCT02768805 (P2), NCT02233816 (P2), NCT02236052 (P2), NCT01991587 (P1/2), Developer website
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Quadrivalent VLPs |
National Health Research Institutes (Taiwan) | Virus-like particles (VLP) | Preclinical | An insect cell-based baculovirus expression system used to generate rBVs bearing influenza HA, NA, and M1 genes from four seasonal influenza vaccine strains which are used to produce insect cell-based VLPs as quadrivalent seasonal influenza vaccine candidates |
rAAV-COBRA |
St Jude Children’s Research Hospital (US) | Virus-vectored | Preclinical | Recombinant adenovirus-associated virus (rAAV) vector expressing a computationally optimized broadly reactive antigen (COBRA)-derived influenza H1 hemagglutinin (HA) with modestly enriched CpG motifs to evoke a robust and long-lasting immune response |
rAd-HA2 |
Health Canada (Canada), University of Ottawa (Canada) | Virus-vectored | Preclinical | Recombinant adenovirus vaccine (rAd) carrying a synthetic HA2 representing the consensus sequence of all influenza B virus HAs |
rAd-NP-M2e-GFP |
Jilin University (China) | Virus-vectored | Preclinical | Packaged recombinant adenovirus rAd-NP-M2e-GFP expressing multiple copies of influenza virus conserved antigens NP and M2e and packaged empty vector adenovirus rAd-GFP |
rAd-SHA2 |
National Institutes for Food and Drug Control (China), Health Canada (Canada) | Virus-vectored | Preclinical | Recombinant adenovirus (rAd) construct encoding secreted fusion protein (codon-optimized HA2 subunit of influenza A virus fused to a trimerized form of murine CD40L). |
rAd/NP + rAd/HA-M2e |
Ewha Womans University (Korea) | Virus-vectored | Preclinical | Recombinant adenovirus-based vaccine that expresses influenza NP, HA, and M2e in a mixture of rAd/NP and rAd/HA-M2e administered intranasally or intramuscularly. |
RAM-IGIP |
University of Georgia (US) | Influenza virus-based | Preclinical | Attenuated MLV (modified live virus) vaccine, built by rearranging FLUAV genome segments and incorporating the IgA-inducing protein |
Reassortant LAIV with modified NS-1 and NP |
Institute of Experimental Medicine (Russia) | Influenza virus-based | Preclinical | Reassortant LAIV expressing modified NP and NS1 genes aimed at inducing a robust T-cell response |
rM2e-ΔPly |
Chongqing Medical University (China) | Recombinant proteins | Preclinical | A novel rM2e-ΔPly protein containing multiple M2e originated from different species of IAV expressed in Escherichia coli (E. coli) |
rMVA-k1-k2 |
Federal Medical-Biological Agency (Russia) | Virus-vectored | Preclinical | Epitope-based vaccine against influenza based on modified vaccinia Ankara (MVA) vector and using an algorithm to select epitopes from conserved fragments of the NP, M1 and HA proteins of influenza A and B |
rNA antigens |
Ghent University (Belgium), Sanofi Pasteur (France) | Recombinant proteins | Preclinical | Computationally engineered consensus NA sequences forming 3 recombinant NA proteins. |
rNP plus BPPcysMPEG |
Helmholtz Centre for Infection Research (Germany), Instituto de Medicina y Biología Experimental de Cuyo (IMBECU) (Argentina) | Recombinant proteins | Preclinical | Recombinant protein based vaccine containing the NP antigen adjuvanted with a TLR2/6 agonist, the BPPcysMPEG adjuvant |
rNP+SLA-SE |
Trudeau Institute (US) | Recombinant proteins | Preclinical | Adjuvanted recombinant nucleoprotein construct; aimed at generating cellular and humoral immunity to conserved influenza A proteins. |
RSM2eFP spore vaccine |
Beijing Institute of Microbiology and Epidemiology (China) | Influenza virus-based | Preclinical | Recombinant influenza vaccine using Bacillus subtilis spores expressing M2e-FP protein (RSM2eFP) administered via aerosolized intratracheal inoculation (i.t.). |
RVJ-4M2eNP |
China CDC (China) | Virus-vectored | Preclinical | Recombinant vaccinia viruses (Tiantan strain) expressing a fusion antigen of NP and 1 or 4 copies of M2e. |
rVSV-EΔM-tM2e |
University of Manitoba (Canada) | Virus-vectored | Preclinical | rVSV-based vaccine candidates expressing the ectodomain of influenza matrix protein (M2e) and/or conserved hemagglutinin stalk regions (HA stalk) fused with the DC-targeting domain of EboGP (E1M) to generate E1M-tM2e or E1M-HM2e, which is UV-inactivated.
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S-FLU |
University of Oxford (UK), University of Melbourne (Australia) | Influenza virus-based | Preclinical | Non-replicating form of pseudotyped influenza virus, inactivated by suppression of the HA signal sequence (S-FLU); aimed at inducing heterotypic protection through activation of cross-reactive T cells in the lung. |
sa-mRNA (SQ012) |
CSL Seqirus (Australia) | Nucleic acid-based | Phase 1 | Self-amplifying mRNA bicistronic influenza vaccine candidate developed to co-express HA and NA Formerly: sa-mRNA bicistronic vaccine Goal |
sa-RNA (ARCT-2138) |
Arcturus Therapeutics (US), CSL Seqirus (Australia) | Nucleic acid-based | Phase 1 | Self-amplifying RNA seasonal influenza vaccine (ARCT-2138) administered intramuscularly Goal |
SAM-GM-CSF + SAM-NP |
GSK (UK) | Nucleic acid-based | Preclinical | Self-amplifying mRNA (SAM) vaccines expressing NP; co-administration of SAM-granulocyte-macrophage colony-stimulating factor (GM-CSF); aimed at inducing NP-specific CD8+ T cells. |
saRNA |
Pfizer (US) | Nucleic acid-based | Phase 2 | Self-amplifying ribonucleic acid (saRNA) vaccine delivered intramuscularly Goal |
Sbmut HA |
Duke University (US) | Recombinant proteins | Preclinical | An HA antigenic mixture–based vaccine with four positions of the Sb antigenic site randomized within the back-bone of an H1 HA |
Scrambled HA (scrHA) |
University of Wisconsin (US) | Recombinant proteins | Preclinical | An H3 HA vaccine antigen with various amino acids at immunodominant epitopes of the HA head domain. |
Self amplifying mRNA |
University of Minnesota (US) | Nucleic acid-based | Preclinical | Self-amplifying mRNA vaccine encoding the influenza A virus nucleoprotein that is encapsulated in modified dendron-based nanoparticles. |
Self assembling peptides displaying M2e and HA2 |
Russian Academy of Sciences (Russia) | Non-VLP nanoparticles | Preclinical | Self-assembling nanoparticles displaying M2e and HA stalk epitopes aimed at inducing humoral and T-cell responses |
Self-assembled multiepitope nanoparticles (MHF) |
Jilin University (China) | Non-VLP nanoparticles | Preclinical | Multiepitope nanovaccine, MHF, made up of conserved linear epitopes of HA2, M2e, and NP fused to either three surface loops on the P domain, or to ferritin. (Formerly: HMN-PP) |
Self-assembled protein nanocages (SAPNs) |
Georgia Institute of Technology (US) | Non-VLP nanoparticles | Preclinical | A broadly cross-reactive influenza vaccine developed by functionalizing self-assembled protein nanocages (SAPNs) with multiple copies of the hemagglutinin stalk on the outer surface and matrix protein 2 ectodomain on the inner surface |
Self-assembling protein nanoparticles (SApNPs) |
Scripps Research Institute (US) | Non-VLP nanoparticles | Preclinical | Single-component self-assembling protein nanoparticles (SApNPs) presenting the conserved extracellular domain of matrix protein 2 (M2e) |
Single ADCC activating peptides |
University of Hong Kong (Hong Kong SAR, China) | Recombinant proteins | Preclinical | Novel constructs based on ADCC-inducing peptide in the HA1 and HA2 regions. |
SpyTagged noro-VLP |
Tampere University (Finland) | Virus-like particles (VLP) | Preclinical | Uses a modular vaccine platform based on the noro-VLP, fused with highly conserved antigens, the ectodomain of M2e protein and a minimized stem-fragment of HA. |
Stabilized headless HA stem nanoparticles |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Non-VLP nanoparticles | Phase 1 | Stabilized headless HA stem trimers on self-assembling nanoparticles; aimed at stimulating broadly protective immunity against novel viruses. Goal Casazza 2024 (PMID: 39289377), Andrews 2023 (PMID: 37075126), Widge 2023 (PMID: 37075129), Moin 2022 (PMID: 36356572), Darricarrère 2021 (PMID: 33658355), Corbett 2019 (PMID: 30808695), Yassine 2015 (PMID: 26301691), Press Release 4-20-2023, Press Release 3-3-2021, NIH Press Release 2019, NCT04579250 (P1), NCT03814720 (P1), NIH Funding, Developer website: NIAID
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Synthetic multicomponent nanovaccine |
University of Quebec at Montreal (Canada) | Non-VLP nanoparticles | Preclinical | Multicomponent nanofilaments, composed of cross-β-sheet nanofilaments exposing the M2e epitope from the influenza virus and the TLR7 agonist IMQ, aimed at inducing a protective M2e-specific immune response. |
T4-M2e VLP |
Huazhong Agricultural University (China) | Virus-like particles (VLP) | Preclinical | T4 VLP construct displaying three tandem copies of M2e from human, swine and avian influenza; aimed at inducing both humoral and cellular immune responses. |
ta-RNA, sa-RNA |
BioNTech (Germany), Johannes Gutenberg University Mainz (Germany) | Nucleic acid-based | Preclinical | RNA vaccine approach based on a novel split-vector system using trans-amplifying RNA (taRNA) or self-amplifying (saRNA) encoding HA antigen. |
Tandiflu1 VLP |
iQur (UK) | Virus-like particles (VLP) | Preclinical | VLP construct based on multiple conserved antigens presented on HepB tandem core platform; HepB core protein + HA stem (H1 and H3) + 3xM2e (from 3 strains) expressed in yeast; 4 conserved IAV antigens contained within a single VLP; aimed at stimulation of cross-reactive and protective polyclonal antibodies. |
TAT-NP |
Shanghai Institute of Biological Products (China) | Recombinant proteins | Preclinical | Recombinant protein construct, based on the conserved protein NP and protein transduction domain TAT; aimed at inducing cross-protective cellular and humoral immune responses. |
Trimeric HA-Fc |
University of Maryland (US) | Recombinant proteins | Preclinical | Monomeric IgG Fc fused to influenza virus hemagglutinin (HA) Ag with a trimerization domain |
TX98-129 |
University of South Dakota (US), University of Illinois Urbana-Champaign (US) | Influenza virus-based | Preclinical | Recombinant influenza virus based vaccine that expresses a chimeric HA (HA-129) derived from HAs of four genetically distinct swine influenza A viruses (H1N1) that had a history of zoonotic transmission. The chimeric HA was obtained through molecular breeding (gene shuffling) technology from the four original parental HAs. Designed to induce broadly protective immunity against genetically divergent HAs. |
VLP cocktail |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Virus-like particles (VLP) | Preclinical | Mixture of VLPs individually displaying H1, H3, H5, and H7 HAs representing group 1 and group 2 viruses; aimed at protecting against circulating and novel influenza A viruses. |
VLP-based vaccine |
TechnoVax (US) | Virus-like particles (VLP) | Preclinical | VLP structures displaying alternative conformations of remodeled HAs displaying conserved subdominant antigenic sites; aimed at promoting an antibody response to neutralize a broad spectrum of influenza viruses. |
VLPs |
Kyung Hee University (S Korea) | Virus-like particles (VLP) | Preclinical | Influenza VLPs expressing hemagglutinin (HA) subtypes (H1, H3, H5) with or without a combination of the following: NA, avian NA subtypes (N1, N6, N8), or M2e5x. |
VRC H1ssF_3928 mRNA-LNP |
National Institute of Allergy and Infectious Diseases (NIAID) (US) | Nucleic acid-based | Phase 1 | mRNA expressing influenza H1 stabilized stem (H1ss) covalently fused to H. pylori ferritin (F) Goal |
VT-105 |
Versatope Therapeutics (US) | Non-VLP nanoparticles | Preclinical | Combines diverse variants of influenza strains displayed on a single nano-sized rOMV (recombinant outer membrane vesicle); VT-105 is based on the M2 protein; targets the virus-infected cell to engage cell-mediated immune responses against all influenza strains. |
VXA-A1.1 oral tablet |
Vaxart (US) | Virus-vectored | Phase 2 | Replication-defective adenovirus type-5 vectored construct that expresses HA; includes a novel toll-like receptor 3 (TLR3 ligand) agonist as an adjuvant; administered orally in tablets designed to release the virus in the ileum, with the potential to stimulate cellular and mucosal immunity and serum antibody. Goal Braun 2023 (PMID: 37562075), Flitter 2022 (PMID: 35455342), McIlwain 2021 (PMID: 34784508), Rudenko 2020 (PMID: 31978351), Liebowitz 2020 (PMID: 31978354), Kolhatkar 2018 (PMCID: PMC6253129), Scallan 2016 (PMID: 27071663), Kim 2016 (PMID: 27881837), Liebowitz 2015 (PMID: 26333337), Peters 2013 (PMID: 23357198), NCT02918006 (P2), NCT03121339 (P1), NCT01688297 (P1), NCT01335347 (P1), Vaxart Investor Presentation Oct 2024, Vaxart Investor Presentation Nov 2023, Press Release 1-22-2020, Press Release 7-9-2019, Developer website
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Wyeth/IL-15/5flu |
University of Hong Kong (Hong Kong SAR, China) | Virus-vectored | Preclinical |
Live, replication competent vaccinia Wyeth Backbone carrying 5 full-length influenza proteins derived from H5N1 viruses (NP, HA NA, M1, and M2) and IL-15 as a molecular adjuvant; aimed at eliciting robust CD4+ and CD8+ T cell responses. |
α-1,3-GT |
University of Hong Kong (Hong Kong SAR, China) | Influenza virus-based | Preclinical | LAIV expressing galactose-α-1,3-galactose (α-Gal) epitopes; aimed at enhancing antigen update, resulting in phagocytosis, NK cell-mediated cell killing and ADCC responses and cross-reactive protection against group 1 and group 2 influenza viruses; administered intranasally. |
α-DEC-205: M2e conjugate |
Universidad Autónoma del Estado de Morelos (Mexico) | Recombinant proteins | Preclinical | M2e peptide chemically cross-linked to a mAb specific for DEC-205, a C-type lectin present on dendritic cells, to induce heterosubtypic protection. |
ΔNS1 virus |
Icahn School of Medicine at Mount Sinai (US) | Influenza virus-based | Preclinical | Live attenuated Influenza A virus lacking the NS1 gene (ΔNS1) expressing cHAs corresponding to the head of H8 and the stalk of H1 (cH8/1) and to the head of H11 and the stalk of H1 (cH11/1); administered intranasally aimed at inducing an innate antiviral response |
