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mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials
Open accessAbstract
BACKGROUND: We evaluated safety and immunogenicity of the first mRNA vaccines against potentially pandemic avian H10N8 and H7N9 influenza viruses. METHODS: Two randomized, placebo-controlled, double-blind, phase 1 clinical trials enrolled participants between December 2015 and August 2017 at single centers in Germany (H10N8) and USA (H7N9). Healthy adults (ages 18-64 years for H10N8 study; 18-49 years for H7N9 study) participated. Participants received vaccine or placebo in a 2-dose vaccination series 3 weeks apart. H10N8 intramuscular (IM) dose levels of 25, 50, 75, 100, and 400 µg and intradermal dose levels of 25 and 50 µg were evaluated. H7N9 IM 10-, 25-, and 50-µg dose levels were evaluated; 2-dose series 6 months apart was also evaluated. Primary endpoints were safety (adverse events) and tolerability. Secondary immunogenicity outcomes included humoral (hemagglutination inhibition [HAI], microneutralization [MN] assays) and cell-mediated responses (ELISPOT assay). RESULTS: H10N8 and H7N9 mRNA IM vaccines demonstrated favorable safety and reactogenicity profiles. No vaccine-related serious adverse event was reported. For H10N8 (N = 201), 100-µg IM dose induced HAI titers ≥ 1:40 in 100% and MN titers ≥ 1:20 in 87.0% of participants. The 25-µg intradermal dose induced HAI titers > 1:40 in 64.7% of participants compared to 34.5% of participants receiving the IM dose. For H7N9 (N = 156), IM doses of 10, 25, and 50 µg achieved HAI titers ≥ 1:40 in 36.0%, 96.3%, and 89.7% of participants, respectively. MN titers ≥ 1:20 were achieved by 100% in the 10- and 25-µg groups and 96.6% in the 50-µg group. Seroconversion rates were 78.3% (HAI) and 87.0% (MN) for H10N8 (100 µg IM) and 96.3% (HAI) and 100% (MN) in H7N9 (50 µg). Significant cell-mediated responses were not detected in either study. CONCLUSIONS: The first mRNA vaccines against H10N8 and H7N9 influenza viruses were well tolerated and elicited robust humoral immune responses. ClinicalTrials.gov NCT03076385 and NCT03345043.
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“Those studies showed that solicited systemic adverse events tended to be more frequent and more severe with higher doses and after the second vaccination.”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [11]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“This descriptive safety profile is similar to that described in a report of two trials of avian influenza mRNA vaccines (influenza A/H10N8 and influenza A/H7N9) that were manufactured by Moderna with the use of an earlier lipid nanoparticle capsule formulation11 and is consistent with an interim report of a phase 1–2 evaluation of a Covid-19 mRNA vaccine encoding the S receptor-binding domain.6”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [11]
In the citing paper
“Two RNA vaccine studies encoding other antigens did not see durable antibody titers in humans or non-human primates”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Feldman et al., 2019
In the citing paper
“Current clinical trials showed that the mRNA-1440 vaccine against H10N8 and the mRNA-1851 vaccine against H7N9 influenza viruses were well tolerated and elicited robust humoral immune responses when tested separately (Table 4).360”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [360]
In the citing paper
“Adverse effects were limited to pain at the injection site, redness, muscle pain, joint pain, headache, fatigue and chills/common-cold-like symptoms, indicating that the vaccine is safe and well tolerated150.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [150]
In the citing paper
“in phase I trials of the Moderna influenza H10N8 vaccine, severe adverse events from the 400 μg dose stopped further evaluation of that dose150.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [150]
In the citing paper
“Moderna already reported on the good tolerability of an intramuscular/intradermal nucleoside-modified mRNA vaccine against two Influenza viruses (H10N8 and H7N9). Typical adverse events related to immune activation such as myalgia, fatigue and headache were reported which were mostly mild to moderate in severity and short-lived, not requiring medical interventions [16]”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [16]
In the citing paper
“Indeed, both i.m. and i.d. administration of lipid nanoparticle–mRNA vaccines produce robust immune responses at a well-tolerated dose in human trials156,157.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [157]
In the citing paper
“Haemagglutinin is an essential surface antigen of influenza viruses156,157.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [157]
In the citing paper
“Lipid nanoparticle–mRNA vaccines are also being investigated as influenza vaccines29,41,156,157,159,184,189–191, with some formulations in clinical trials (Table 1).”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [157]
In the citing paper
“A 100-μg dose level induced 78.3% (HAI) and 87.0% (MN) seroconversion for H10N8 (refs156,157) and a 50-μg dose level resulted in 96.3% (HAI) and 100% (MN) seroconversion for H7N9 (refs156,157).”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [157]
In the citing paper
“A 100-μg dose level induced 78.3% (HAI) and 87.0% (MN) seroconversion for H10N8 (refs156,157) and a 50-μg dose level resulted in 96.3% (HAI) and 100% (MN) seroconversion for H7N9 (refs156,157).”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [157]
In the citing paper
“The mRNA-1440 and mRNA-1851 vaccines, which are composed of lipid nanoparticles and mRNA encoding haemagglutinin from H10N8 and H7N9 influenza viruses, respectively, have completed phase I clinical studies (NCT03076385 and NCT03345043)156,157.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [157]
In the citing paper
“Initial results with lipid-nanoparticle-formulated mRNA vaccines against H10N8 and H7N9 influenza viruses and SARS-CoV-2 indicate that these vaccines are well tolerated and that they produce a robust humoral response 76,77 .”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [77]
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Meulewaeter, S., Aernout, I., Deprez, J., Engelen, Y., Velder, M. D., Franceschini, L., Breckpot, K., Calenbergh, S. V., Asselman, C., Boucher, K. L., et al. (2024) · Journal of Controlled Release · doi:10.1016/j.jconrel.2024.04.052 · Cited by 46
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Understanding Intracellular Biology to Improve mRNA Delivery by Lipid Nanoparticles
Hunter, M. R., Cui, L., Porebski, B. T., Pereira, S. G. T., Sonzini, S., Odunze, U., Iyer, P., Engkvist, O., Lloyd, R. L., Peel, S. E., et al. (2023) · Small Methods · doi:10.1002/smtd.202201695 · Cited by 44
Engineered mRNA Delivery Systems for Biomedical Applications
Wang, J., Zhu, H., Gan, J., Liang, G., Li, L., & Zhao, Y. (2023) · Advanced Materials · doi:10.1002/adma.202308029 · Cited by 46
Scope and challenges of nanoparticle-based mRNA delivery in cancer treatment
Karim, M. E., Haque, S. T., Al-Busaidi, H., Bakhtiar, A., Tha, K. K., Holl, M. M. B., & Chowdhury, E. H. (2022) · Archives of Pharmacal Research · doi:10.1007/s12272-022-01418-x · Cited by 45
Rohde, C. M., Lindemann, C., Giovanelli, M. A., Sellers, R. S., Diekmann, J., Choudhary, S., Ramaiah, L., Vogel, A. B., Chervona, Y., Muik, A., et al. (2023) · Vaccines · doi:10.3390/vaccines11020417 · Cited by 44
The Development of mRNA Vaccines for Infectious Diseases: Recent Updates
Nitika, Wei, J., & Hui, A. (2021) · Infection and Drug Resistance · doi:10.2147/idr.s341694 · Cited by 42
Knudson, C. J., Alves-Peixoto, P., Muramatsu, H., Stotesbury, C., Tang, L., Lin, P. J. C., Tam, Y. K., Weissman, D., Pardi, N., & Sigal, L. J. (2021) · Molecular Therapy · doi:10.1016/j.ymthe.2021.05.011 · Cited by 39
Deyhimfar, R., Izady, M., Shoghi, M., Kazazi, M. H., Ghazvini, Z. F., Nazari, H., Fekrirad, Z., & Arefian, E. (2024) · Heliyon · doi:10.1016/j.heliyon.2024.e26971 · Cited by 42
Jarak, I., Pereira‐Silva, M., Paiva‐Santos, A. C., Veiga, F., Cabral, H., & Figueiras, A. (2021) · Applied Materials Today · doi:10.1016/j.apmt.2021.101217 · Cited by 41
Rational design of lipid nanoparticles for enabling gene therapies
Brimacombe, C. A., Kulkarni, J. A., Cheng, M. H. Y., An, K., Witzigmann, D., & Cullis, P. R. (2025) · Molecular Therapy — Methods & Clinical Development · doi:10.1016/j.omtm.2025.101518 · Cited by 45
“4 The clinical utility of an LNP mRNA vaccine was subsequently demonstrated by Moderna for a flu vaccine 194 and then by CureVac for a rabies vaccine.”
Chan, L., Alizadeh, K., Alizadeh, K., Fazel, F., Kakish, J. E., Karimi, N., Knapp, J. P., Mehrani, Y., Minott, J. A., Morovati, S., et al. (2021) · Vaccines · doi:10.3390/vaccines9090979 · Cited by 40
Lipid-based colloidal nanoparticles for applications in targeted vaccine delivery
Khan, M. S., Appak‐Baskoy, S., Yang, C. J., Hong, J., Chae, J., Ha, H.-J., Lee, S., Tanaka, M., Choi, Y., & Choi, J. H. (2023) · Nanoscale Advances · doi:10.1039/d2na00795a · Cited by 37
Nanocarrier vaccine therapeutics for global infectious and chronic diseases
Simnani, F. Z., Singh, D., Patel, P., Choudhury, A., Sinha, A., Nandi, A., Samal, S. K., Verma, S. K., & Panda, P. K. (2023) · Materials Today · doi:10.1016/j.mattod.2023.04.008 · Cited by 38
Antigen modifications improve nucleoside-modified mRNA-based influenza virus vaccines in mice
Freyn, A. W., Pine, M., Rosado, V. C., Benz, M., Muramatsu, H., Beattie, M. B., Tam, Y. K., Krammer, F., Palese, P., Nachbagauer, R., et al. (2021) · Molecular Therapy — Methods & Clinical Development · doi:10.1016/j.omtm.2021.06.003 · Cited by 37
A Short History of Vaccination
Plotkin, S. L., & Plotkin, S. A. (2023) · Elsevier eBooks · doi:10.1016/b978-0-323-79058-1.00001-3 · Cited by 43
Rcheulishvili, N., Mao, J., Papukashvili, D., Liu, C., Wang, Z., Zhao, J., Xie, F., Pan, X., Ji, Y., He, Y., et al. (2022) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2022.12.066 · Cited by 41
Demystifying mRNA vaccines: an emerging platform at the forefront of cryptic diseases
Rouf, N. Z., Biswas, S., Tarannum, N., Oishee, L. M., & Muna, M. M. (2022) · RNA Biology · doi:10.1080/15476286.2022.2055923 · Cited by 39
“Phase one clinical trials of two non-replicating mRNA vaccines against influenza viruses (H10N8 and H7N9) have been carried out and both vaccines were found to be safe and effective in eliciting an immune response [189].”
BackgroundVaccines to prevent genital herpes
Egan, K. P., Hook, L. M., LaTourette, P., Desmond, A., Awasthi, S., & Friedman, H. M. (2020) · Translational research · doi:10.1016/j.trsl.2020.03.004 · Cited by 37
Influenza Viruses: Innate Immunity and mRNA Vaccines
Lee, S., & Ryu, J. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.710647 · Cited by 36
mRNA vaccines against respiratory viruses
Whitaker, J. A., Sahly, H. M. E., & Healy, C. M. (2023) · Current Opinion in Infectious Diseases · doi:10.1097/qco.0000000000000948 · Cited by 39
“The first mRNA influenza vaccine phase 1 clinical trials consisted of chemically modified mRNAs encoding the full-length, membrane-bound form of the hemagglutinin glycoprotein from the H10N8 and H7N9 strains in a LNP delivery system [47] (Table 1).”
BackgroundRecent Progress in Recombinant Influenza Vaccine Development Toward Heterosubtypic Immune Response
Carascal, M. B., Pavon, R. D. N., & Rivera, W. L. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.878943 · Cited by 37
Current state of, prospects for, and obstacles to mRNA vaccine development
Aljabali, A. A. A., Bashatwah, R. M., Obeid, M. A., Mishra, V., Mishra, Y., Serrano‐Aroca, Á., Lundstrom, K. H., & Tambuwala, M. M. (2022) · Drug Discovery Today · doi:10.1016/j.drudis.2022.103458 · Cited by 35
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Targeting the hallmarks of aging to improve influenza vaccine responses in older adults
Cadar, A. N., Martin, D. E., & Bartley, J. M. (2023) · Immunity & Ageing · doi:10.1186/s12979-023-00348-6 · Cited by 34
“While these trials were successful and showed induction of protective antibody responses [82, 83], it is hard to predict if similar success would be evident in older adults.”
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“One vaccine utilizing this method is VAL-506440 and VAL-339851, which are mRNA HA from H10N8 and H7N9 influenza strains delivered in a lipid nanoparticle (LNP) [92].”
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“4 and 2 trials that are completed (3, 4) or currently underway (5-7).”
BackgroundPolymeric Nanocarrier Formulations of Biologics Using Inverse Flash NanoPrecipitation
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Lipid- and Polymer-Based Nanocarrier Platforms for Cancer Vaccine Delivery
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Immunological perspectives on the pathogenesis, diagnosis, prevention and treatment of COVID-19
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Construction and Immunogenicity of Modified mRNA-Vaccine Variants Encoding Influenza Virus Antigens
Starostina, E. V., Sharabrin, S. V., Antropov, D. N., Stepanov, G. A., Shevelev, G. Y., Lemza, A. E., Рудометов, А. П., Borgoyakova, M. B., Борисовна, Р. Н., Marchenko, V. Y., et al. (2021) · Vaccines · doi:10.3390/vaccines9050452 · Cited by 28
“Pseudouridine and its methylated derivation N1-methyl pseudouridine are actively used for constructing artificial mRNAs, including mRNA vaccines [10,20].”
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mRNA, the beginning of a new influenza vaccine game
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“7% participants of H10N8 and H7N9 studies, respectively (7).”
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“–238 This discrepancy may stem from the HA’s weak T cell antigenicity.”
Design principles of lipid nanoparticles for RNA delivery
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The Novelty of mRNA Viral Vaccines and Potential Harms: A Scoping Review
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“Using an LNP–mRNA platform here is better than supplying the protein itself, as a protein expressed from IVT RNA is more likely to have the correct post-transcriptional modifications (and subsequent conformation) for its target cell type than an exogenously supplied protein [90].”
Background
Metadata
- Authors
- Feldman, R. A., Fuhr, R., Smolenov, I., (Mick) Ribeiro, A., Panther, L., Watson, M., Senn, J. J., Smith, M., Almarsson, Ӧ., Pujar, H. S., Laska, M. E., Thompson, J., Zaks, T., & Ciaramella, G.
- Affiliations
- Moderna Therapeutics (United States) (US)
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2019-05
- Volume
- 37
- Issue
- 25
- Pages
- 3326-3334
- ISSN
- 0264-410X (ISSN-L)
- OpenAlex
- W2944588091
- Cited by
- 454
- References
- 36
- Citations by year
- 2026: 27 · 2025: 41 · 2024: 66 · 2023: 60 · 2022: 87 · 2021: 114 · 2020: 53 · 2019: 6
- FWCI
- 49.46
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Vaccine (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Moderna
- Topics
- Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
- Keywords
- mRNA vaccines, H7N9 influenza virus, pandemic influenza preparedness, vaccine safety, vaccine immunogenicity, intradermal vaccination, intramuscular vaccination, dose escalation, hemagglutination inhibition, microneutralization, cell-mediated immunity, healthy adults, reactogenicity, healthy volunteers, vaccine tolerability
- MeSH terms
- Immunogenicity, Vaccine, Adolescent, Adult, Antibodies, Viral, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Influenza, Human, Influenza Vaccines, Male, Middle Aged, RNA, Viral, Young Adult, Healthy Volunteers, Influenza A Virus, H7N9 Subtype, Influenza A Virus, H10N8 Subtype
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