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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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“Importantly, immunization with chemically modified mRNA encapsulated within a lipid nanoparticle was found to be safe and immunogenic in humans following a Phase 1 clinical trial using an mRNA vaccine targeting H10N8 influenza.(34,35) Here we evaluated LNP-encapsulated chemically modified mRNA vaccines encoding variou…”
BackgroundSelf-citationCombinatorial development of nebulized mRNA delivery formulations for the lungs
Jiang, A. Y., Witten, J. J., Raji, I. O., Eweje, F., MacIsaac, C., Meng, S., Oladimeji, F. A., Hu, Y., Manan, R. S., Langer, R., et al. (2023) · Nature Nanotechnology · doi:10.1038/s41565-023-01548-3 · Cited by 215
Nucleic acid drugs: recent progress and future perspectives
Sun, X., Setrerrahmane, S., Li, C., Hu, J., & Xu, H. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-02035-4 · Cited by 225
Novel vaccine technologies for the 21st century
Mascola, J. R., & Fauci, A. S. (2020) · Nature Reviews Immunology · doi:10.1038/s41577-019-0243-3 · Cited by 171
Eliciting B cell immunity against infectious diseases using nanovaccines
Singh, A. (2021) · Nature Nanotechnology · doi:10.1038/s41565-020-00790-3 · Cited by 169
Prediction of lipid nanoparticles for mRNA vaccines by the machine learning algorithm
Wang, W., Feng, S., Ye, Z., Gao, H., Lin, J., & Ouyang, D. (2021) · Acta Pharmaceutica Sinica B · doi:10.1016/j.apsb.2021.11.021 · Cited by 173
mRNA cancer vaccines: Advances, trends and challenges
He, Q., Gao, H., Tan, D., Zhang, H., & Wang, J. (2022) · Acta Pharmaceutica Sinica B · doi:10.1016/j.apsb.2022.03.011 · Cited by 171
Coronavirus Disease (COVID-19): Current Status and Prospects for Drug and Vaccine Development
Ita, K. B. (2020) · Archives of Medical Research · doi:10.1016/j.arcmed.2020.09.010 · Cited by 164
Research Advances on the Stability of mRNA Vaccines
Cheng, F., Wang, Y., Bai, Y., Liang, Z., Mao, Q., Liu, D., Wu, X., & Xu, M. (2023) · Viruses · doi:10.3390/v15030668 · Cited by 177
“mRNA vaccines are currently undergoing clinical trials for the prevention and control of diseases other than COVID-19 vaccines, including vaccines for influenza [24], human immunodeficiency virus (NCT05001373), Zika virus (NCT04064905), respiratory syncytial virus (NCT04528719), and cytomegalovirus (NCT04232280).”
BackgroundImmune Responses Induced by mRNA Vaccination in Mice, Monkeys and Humans
Cagigi, A., & Loré, K. (2021) · Vaccines · doi:10.3390/vaccines9010061 · Cited by 153
“Detectable CD4+ T cell- and not CD8+ T cell- responses were induced in rhesus macaques to this vaccine [8,21], but the clinical phase I study did not find detectable T cell responses in vaccinated individuals [30,56].”
BackgroundAliprantis, A. O., Shaw, C. A., Griffin, P., Farinola, N., Railkar, R. A., Cao, X., Liu, W., Sachs, J. R., Swenson, C. J., Lee, H., et al. (2021) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2020.1829899 · Cited by 149
Self-citationmRNA vaccine in cancer therapy: Current advance and future outlook
Li, Y., Wang, M., Peng, X., Yang, Y., Chen, Q., Liu, J., She, Q., Tan, J., Lou, C., Liao, Z., et al. (2023) · Clinical and Translational Medicine · doi:10.1002/ctm2.1384 · Cited by 158
Chatzikleanthous, D., O’Hagan, D. T., & Adamo, R. (2021) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.1c00447 · Cited by 152
Chaudhary, N., Kasiewicz, L. N., Newby, A. N., Arral, M. L., Yerneni, S. S., Melamed, J. R., LoPresti, S. T., Fein, K. C., Petersen, D. M. S., Kumar, S., et al. (2024) · Nature Biomedical Engineering · doi:10.1038/s41551-024-01256-w · Cited by 153
“This limitation probably limited the production of neutralizing antibodies by B cells for anti-viral vaccines or efficient cancer cell destruction by T cells for cancer vaccine applications 12,18–20 .”
Highly pathogenic avian influenza H5N1: history, current situation, and outlook
Krammer, F., Hermann, E., & Rasmussen, A. L. (2025) · Journal of Virology · doi:10.1128/jvi.02209-24 · Cited by 139
“…historic H7 and H10 avian influenza virus vaccines developed by Moderna also induced extremely high titers in the ferret model but then performed poorly in humans (106, 107), suggesting a poor predictive value of animal models for protective efficacy of mRNA-based avian influenza virus vaccines.”
The immunostimulatory nature of mRNA lipid nanoparticles
Sharma, P., Hoorn, D., Aitha, A., Breier, D., & Peer, D. (2024) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2023.115175 · Cited by 132
Nanoplatforms for mRNA Therapeutics
Meng, C., Chen, Z., Li, G., Welte, T., & Shen, H. (2021) · Advanced Therapeutics · doi:10.1002/adtp.202000099 · Cited by 130
Enhancing RNA-lipid nanoparticle delivery: Organ- and cell-specificity and barcoding strategies
Wei, P.-S., Thota, N., John, G., Chang, E., Lee, S., Wang, Y., Ma, Z., Tsai, Y.-H., & Mei, K. (2024) · Journal of Controlled Release · doi:10.1016/j.jconrel.2024.08.030 · Cited by 138
“Clinical trials are currently underway for next-generation vaccines aimed at preventing influenza, HIV/AIDS, and rabies [232 – 236].”
Lipid Nanoparticles as Delivery Vehicles for Inhaled Therapeutics
Leong, E. W. X., & Ge, R. (2022) · Biomedicines · doi:10.3390/biomedicines10092179 · Cited by 134
“Moderna first tested mRNA vaccines against H10N8 and H7N9 influenza strains delivered in LNPs and found them to be well tolerated and immunogenic in randomized, placebo-controlled, double-blind, Phase 1 clinical trials (NCT03076385 and NCT03345043) [51].”
BackgroundCOVID-19 vaccines for patients with cancer: benefits likely outweigh risks
Hwang, J. K., Zhang, T., Wang, A. Z., & Li, Z. (2021) · Journal of Hematology & Oncology · doi:10.1186/s13045-021-01046-w · Cited by 127
Kowalzik, F., Schreiner, D., Jensen, C., Teschner, D., Gehring, S., & Zepp, F. (2021) · Vaccines · doi:10.3390/vaccines9040390 · Cited by 133
SARS-CoV-2 (Covid-19) vaccines structure, mechanisms and effectiveness: A review
Fathizadeh, H., Afshar, S., Masoudi, M. R., Gholizadeh, P., Asgharzadeh, M., Ganbarov, K., Köse, Ş., Yousefi, M., & Kafil, H. S. (2021) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2021.08.076 · Cited by 126
Influenza vaccines: Past, present, and future
Kim, Y. H., Hong, K., Kim, H., & Nam, J. (2021) · Reviews in Medical Virology · doi:10.1002/rmv.2243 · Cited by 123
“mRNA vaccines for influenza virus exhibited protective effects in mice, immunogenic responses and safety in human clinical trials, and cross‐protection effect by eliciting influenza virus HA stalk‐specific antibodies.(149,150) Adjuvants,”
BackgroundDevelopment of multivalent mRNA vaccine candidates for seasonal or pandemic influenza
Chivukula, S., Plitnik, T., Tibbitts, T., Karve, S., Dias, A., Zhang, D., Goldman, R., Gopani, H., Khanmohammed, A., Sarode, A., et al. (2021) · npj Vaccines · doi:10.1038/s41541-021-00420-6 · Cited by 117
Analysis of COVID‐19 vaccines: Types, thoughts, and application
Han, X., Xu, P., & Ye, Q. (2021) · Journal of Clinical Laboratory Analysis · doi:10.1002/jcla.23937 · Cited by 119
Nanotechnology-empowered vaccine delivery for enhancing CD8+ T cells-mediated cellular immunity
Liu, G., Zhu, M., Zhao, X., & Nie, G. (2021) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.113889 · Cited by 114
mRNA vaccines for COVID-19 and diverse diseases
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“Various mRNA vaccines are undergoing clinical trials, such as modified mRNA VAL-506440 encoding full-length, a membrane-bound form of the HA glycoprotein isolated from either of the two prominent strains, H10N8 influenza strain and H7N9 influenza strain (Table 5) [169] [170].”
Engineering of the current nucleoside-modified mRNA-LNP vaccines against SARS-CoV-2
Granados-Riveron, J. T., & Aquino‐Jarquín, G. (2021) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2021.111953 · Cited by 115
From COVID-19 to Cancer mRNA Vaccines: Moving From Bench to Clinic in the Vaccine Landscape
Chakraborty, C., Sharma, A. R., Bhattacharya, M., & Lee, S. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.679344 · Cited by 114
Current Developments and Challenges of mRNA Vaccines
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The early landscape of coronavirus disease 2019 vaccine development in the UK and rest of the world
Sharpe, H., Gilbride, C., Allen, E. R., Belij‐Rammerstorfer, S., Bissett, C., Ewer, K., & Lambe, T. (2020) · Immunology · doi:10.1111/imm.13222 · Cited by 103
Haghighi, E., Abolmaali, S. S., Dehshahri, A., Shaegh, S. A. M., Azarpira, N., & Tamaddon, A. M. (2024) · Journal of Nanobiotechnology · doi:10.1186/s12951-024-02972-w · Cited by 125
Extracellular vesicles versus lipid nanoparticles for the delivery of nucleic acids
Bader, J., Brigger, F., & Leroux, J. (2024) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2024.115461 · Cited by 110
Advances in gene-based vaccine platforms to address the COVID-19 pandemic
Pushparajah, D., Jimenez, S., Wong, S. L., Alattas, H., Nafissi, N., & Slavcev, R. A. (2021) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.01.003 · Cited by 99
Garg, I., Shekhar, R., Sheikh, A. B., & Pal, S. (2021) · Infectious Disease Reports · doi:10.3390/idr13030064 · Cited by 104
New vaccine production platforms used in developing SARS-CoV-2 vaccine candidates
Ura, T., Yamashita, A., Mizuki, N., Okuda, K., & Shimada, M. (2020) · Vaccine · doi:10.1016/j.vaccine.2020.11.054 · Cited by 97
The Pivotal Role of Chemical Modifications in mRNA Therapeutics
Liu, A., & Wang, X. (2022) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2022.901510 · Cited by 102
“A vaccine candidate against H10N8 and H7N9 entered phase I trials in 2015 (Feldman et al., 2019), and two other candidates (mRNA-1010 and PF-07252220) entered phase I trials in late 2021.”
BackgroundNucleic Acid Vaccines for COVID-19: A Paradigm Shift in the Vaccine Development Arena
Chavda, V. P., Hossain, M. M. M., Beladiya, J., & Apostolopoulos, V. (2021) · Biologics · doi:10.3390/biologics1030020 · Cited by 92
Development of mRNA Lipid Nanoparticles: Targeting and Therapeutic Aspects
Liu, Y., Huang, Y., He, G., Guo, C., Dong, J., & Wu, L. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms251810166 · Cited by 100
Engineering nanoparticle toolkits for mRNA delivery
Sun, B., Wu, W., Narasipura, E. A., Ma, Y., Yu, C., Fenton, O. S., & Song, H. (2023) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2023.115042 · Cited by 96
The coronavirus disease 2019 vaccine in pregnancy: risks, benefits, and recommendations
Stafford, I. A., Parchem, J. G., & Sibai, B. M. (2021) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2021.01.022 · Cited by 89
How COVID unlocked the power of RNA vaccines
Dolgin, E. (2021) · Nature · doi:10.1038/d41586-021-00019-w · Cited by 90
Assessing the generation of tissue resident memory T cells by vaccines
Rotrosen, E. T., & Kupper, T. S. (2023) · Nature reviews. Immunology · doi:10.1038/s41577-023-00853-1 · Cited by 91
Adjuvant physiochemistry and advanced nanotechnology for vaccine development
Ren, H., Jia, W., Xie, Y., Yu, M., & Chen, Y. (2023) · Chemical Society Reviews · doi:10.1039/d2cs00848c · Cited by 91
Li, X., Qi, J., Wang, J., Hu, W., Zhou, W., Wang, Y., & Li, T. (2024) · Theranostics · doi:10.7150/thno.84291 · Cited by 100
“These results indicate that the use of LNP-formulated mRNA is a promising vaccine platform for influenza prevention, and the ongoing development of mRNA vaccines holds great potential to further improve influenza prevention and control [137].”
ResultSynthetic modified messenger RNA for therapeutic applications
Gao, M., Zhang, Q., Feng, X.-H., & Liu, J. (2021) · Acta Biomaterialia · doi:10.1016/j.actbio.2021.06.020 · Cited by 89
Synthetic Messenger RNA-Based Vaccines: From Scorn to Hype
Pascolo, S. (2021) · Viruses · doi:10.3390/v13020270 · Cited by 87
“human clinical studies as prophylactic vaccines against viruses: including influenza (with a dose range between 25 and 400 μg intramuscular or intradermal) [23] and rabies (with a dose range between 80 and 640 μg via intramuscular or intradermal administration) [24].”
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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