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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Prior studies showed that solicited systemic adverse events tended to be more frequent and more severe with higher doses and after the second vaccination.
“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]
The H10N8 Results (§3.2.1; page unavailable) report that fever increased with dose and was more frequent after the second dose in the 100-mg group. The H7N9 Results (§3.2.2; page unavailable) report that 11 of 12 severe solicited events occurred in the highest-dose group, but explicitly state that, except for fever in that group, solicited-event frequency did not increase after the second vaccination. The source therefore supports a dose-related pattern and limited post-second-dose increases, not a general increase in the frequency and severity of systemic events after the second vaccination. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe descriptive safety profile of mRNA-1273 is similar to that of avian influenza mRNA vaccines and consistent with an interim report of a Covid-19 mRNA vaccine encoding the S receptor-binding domain.
“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]
Two RNA vaccine studies encoding other antigens did not observe durable antibody titers in humans or non-human primates.
“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
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.
“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]
Adverse effects of the Moderna influenza candidates 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 tolerated.
“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 phase I trials of the Moderna influenza H10N8 vaccine, severe adverse events from the 400 μg dose stopped further evaluation of that dose.
“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]
Moderna reported good tolerability of an intramuscular/intradermal nucleoside-modified mRNA vaccine against influenza viruses H10N8 and H7N9, with typical adverse events mostly mild to moderate and short-lived.
“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]
Both i.m. and i.d. administration of lipid nanoparticle-mRNA vaccines produce robust immune responses at a well-tolerated dose in human trials.
“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]
Haemagglutinin is an essential surface antigen of influenza viruses.
“Haemagglutinin is an essential surface antigen of influenza viruses156,157.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [157]
Lipid nanoparticle-mRNA vaccines are being investigated as influenza vaccines, with some formulations in clinical trials.
“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]
A 50-μg dose level resulted in 96.3% (HAI) and 100% (MN) seroconversion for H7N9.
“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]
A 100-μg dose level induced 78.3% (HAI) and 87.0% (MN) seroconversion for H10N8.
“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]
The mRNA-1440 and mRNA-1851 vaccines, composed of lipid nanoparticles and mRNA encoding haemagglutinin from H10N8 and H7N9 influenza viruses, respectively, have completed phase I clinical studies.
“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]
Lipid-nanoparticle-formulated mRNA vaccines against H10N8 and H7N9 influenza viruses and SARS-CoV-2 are well tolerated and produce a robust humoral response.
“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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Kon, E., Ad‐El, N., Hazan‐Halevy, I., Stotsky‐Oterin, L., & Peer, D. (2023) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-023-00811-9 · Cited by 385 · see citing works
“For example, cancer vaccine doses typically used clinically are in the microgram per kilogram range, whereas in mice they can reach ≥0.25 mg/kg 67,130,135 .”
BackgroundInfluentialLaczko, D. I., Hogan, M. J., Toulmin, S. A., Hicks, P. D., Lederer, K., Gaudette, B. T., Castaño, D., Amanat, F., Muramatsu, H., Oguin, T. H., et al. (2020) · Immunity · doi:10.1016/j.immuni.2020.07.019 · Cited by 366 · see citing works
“Of note, a very limited amount of published human clinical data are available on the safety and efficacy of mRNA-LNPs (Bahl et al., 2017; Feldman et al., 2019), and no mRNA vaccines for humans have been licensed to date.”
mRNA Vaccine Era—Mechanisms, Drug Platform and Clinical Prospection
Xu, S., Yang, K., Li, R., & Zhang, L. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21186582 · Cited by 368 · see citing works
“LNP Intravenous Human Melanoma [94] LNP Intramuscular Human H10N8 and H7N9 [95,96]”
BackgroundInfluentialImpact of mRNA chemistry and manufacturing process on innate immune activation
Nelson, J., Sorensen, E. W., Mintri, S., Rabideau, A. E., Zheng, W., Besin, G., Khatwani, N., Su, S. V., Miracco, E. J., Issa, W. J., et al. (2020) · Science Advances · doi:10.1126/sciadv.aaz6893 · Cited by 354 · see citing works
Novel approaches for vaccine development
Gebre, M. S., Brito, L. A., Tostanoski, L. H., Edwards, D. K., Carfi, A., & Barouch, D. H. (2021) · Cell · doi:10.1016/j.cell.2021.02.030 · Cited by 347 · see citing works
“Phase I clinical data showed 100% seroconversion with 25 and 100-μg dose of modified uridine mRNA, respectively, with an adverse event profile similar to other approved vaccines (Feldman et al., 2019).”
Three decades of messenger RNA vaccine development
Verbeke, R., Lentacker, I., De Smedt, S. C., & Dewitte, H. (2019) · Nano Today · doi:10.1016/j.nantod.2019.100766 · Cited by 342 · see citing works
Next-generation influenza vaccines: opportunities and challenges
Wei, C., Crank, M. C., Shiver, J. W., Graham, B. S., Mascola, J. R., & Nabel, G. J. (2020) · Nature Reviews Drug Discovery · doi:10.1038/s41573-019-0056-x · Cited by 324 · see citing works
Freyn, A. W., Ramos da Silva, J., Rosado, V. C., Bliss, C. M., Pine, M., Mui, B. L., Tam, Y. K., Madden, T. D., de Souza Ferreira, L. C., Weissman, D., et al. (2020) · Molecular Therapy · doi:10.1016/j.ymthe.2020.04.018 · Cited by 299 · see citing works
“This low dose of vaccination is promising, as a major limitation to mRNA vaccines has been side effects associated with high doses of LNP, causing inflammation at the injection site.(57)”
BackgroundAn Update on Self-Amplifying mRNA Vaccine Development
Blakney, A. K., Ip, S., & Geall, A. J. (2021) · Vaccines · doi:10.3390/vaccines9020097 · Cited by 288 · see citing works
“The use of mRNA vaccines for pandemic response has been well described previously in preclinical[12-25] and clinical settings,[16] but this is the first time we have seen the platforms deployed in a real pandemic setting.”
BackgroundmRNA-based therapeutics: looking beyond COVID-19 vaccines
Parhiz, H., Atochina‐Vasserman, E. N., & Weissman, D. (2024) · The Lancet · doi:10.1016/s0140-6736(23)02444-3 · Cited by 296 · see citing works
Jung, H. N., Lee, S.-Y., Lee, S., Youn, H., & Im, H.-J. (2022) · Theranostics · doi:10.7150/thno.77259 · Cited by 282 · see citing works
“The inoculation of the mRNA-1440 vaccine administered as two doses of the vaccine 3 weeks apart showed 78.3% inhibition of haemagglutinin at 100 μg in healthy people aged 18-64 years (NCT03076385) and 96.3% inhibition by the inoculation of mRNA-1851 at 50 μg in healthy people aged 18-49 years (NCT03345043) [123].”
BackgroundInfluentialFrom influenza to COVID-19: Lipid nanoparticle mRNA vaccines at the frontiers of infectious diseases
Pilkington, E. H., Suys, E. J. A., Trevaskis, N. L., Wheatley, A. K., Zukancic, D., Algarni, A., Al-Wassiti, H. A., Davis, T. P., Pouton, C. W., Kent, S. J., et al. (2021) · Acta Biomaterialia · doi:10.1016/j.actbio.2021.06.023 · Cited by 265 · see citing works
Recent advances in mRNA-LNP therapeutics: immunological and pharmacological aspects
Kiaie, S. H., Zolbanin, N. M., Ahmadi, A., Bagherifar, R., Valizadeh, H., Kashanchi, F., & Jafari, R. (2022) · Journal of Nanobiotechnology · doi:10.1186/s12951-022-01478-7 · Cited by 261 · see citing works
“For example, several studies demonstrated that mRNA-based influenza vaccines elicit a significantly protective immune response against heterosubtypic and homologous influenza viruses [8, 191].”
ResultControlling timing and location in vaccines
Irvine, D. J., Aung, A., & Silva, M. (2020) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2020.06.019 · Cited by 251 · see citing works
“Recent clinical trials from Moderna using intramuscular delivery of nucleosidemodified RNA show thatmRNA vaccines are safe and capable of inducing effective humoral responses against H10N8 and H7N9 influenza strains in humans [294].”
Polysarcosine-functionalized lipid nanoparticles for therapeutic mRNA delivery
Nogueira, S. S., Schlegel, A., Maxeiner, K., Weber, B., Barz, M., Schroer, M. A., Blanchet, C. E., Svergun, D. I., Ramishetti, S., Peer, D., et al. (2020) · ACS Applied Nano Materials · doi:10.1021/acsanm.0c01834 · Cited by 252 · see citing works
Emerging mRNA technologies: delivery strategies and biomedical applications
Xiao, Y., Tang, Z., Huang, X., Chen, W., Zhou, J., Liu, H., Liu, C., Kong, N., & Tao, W. (2022) · Chemical Society Reviews · doi:10.1039/d1cs00617g · Cited by 255 · see citing works
mRNA vaccines in disease prevention and treatment
Zhang, G., Tang, T., Chen, Y., Huang, X., & Liang, T. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01579-1 · Cited by 253 · see citing works
“119 In 2021, Chivukula et al. used unmodi fi ed and LNP-encapsulated mRNA encoding full-length HA or full-length neuraminidase (NA).”
BackgroundLipid Nanoparticles as Delivery Systems for RNA-Based Vaccines
Aldosari, B. N., Alfagih, I. M., & Almurshedi, A. S. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13020206 · Cited by 242 · see citing works
mRNA vaccines for infectious diseases — advances, challenges and opportunities
Pardi, N., & Krammer, F. (2024) · Nature Reviews Drug Discovery · doi:10.1038/s41573-024-01042-y · Cited by 246 · see citing works
“The haemagglutinin-based H10 vaccine induced very high HAI titres in ferrets, reaching ~1:3,000, which is typically very hard to induce with traditional vaccine platforms 97,176 .”
InfluentialEndosomal escape of delivered mRNA from endosomal recycling tubules visualized at the nanoscale
Paramasivam, P., Franke, C., Stöter, M., Höijer, A., Bartesaghi, S., Sabirsh, A., Lindfors, L., Arteta, M. Y., Dahlén, A., Bak, A., et al. (2021) · The Journal of Cell Biology · doi:10.1083/jcb.202110137 · Cited by 228 · see citing works
Chu, L., McPhee, R. A., Huang, W., Bennett, H., Pajón, R., Nestorova, B., & Leav, B. A. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.02.007 · Cited by 225 · see citing works
Nanomedicines to Deliver mRNA: State of the Art and Future Perspectives
Gómez-Aguado, I., Rodríguez-Castejón, J., Vicente-Pascual, M., Rodríguez‐Gascón, A., Solinís, M. Á., & del Pozo‐Rodríguez, A. (2020) · Nanomaterials · doi:10.3390/nano10020364 · Cited by 224 · see citing works
Formulation and Delivery Technologies for mRNA Vaccines
Zeng, C., Zhang, C., Walker, P. G., & Dong, Y. (2020) · Current topics in microbiology and immunology · doi:10.1007/82_2020_217 · Cited by 221 · see citing works
Progress and prospects of mRNA-based drugs in pre-clinical and clinical applications
Shi, Y., Shi, M., Wáng, Y., & You, J. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-02002-z · Cited by 231 · see citing works
August, A., Attarwala, H. Z., Himansu, S., Kalidindi, S., Lu, S., Pajón, R., Han, S., Lecerf, J., Tomassini, J. E., Hard, M., et al. (2021) · Nature Medicine · doi:10.1038/s41591-021-01573-6 · Cited by 199 · see citing works
Self-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 191 · see citing works
Espeseth, A. S., Cejas, P. J., Citron, M. P., Wang, D., DiStefano, D. J., Callahan, C., Donnell, G. O., Galli, J. D., Swoyer, R., Touch, S., et al. (2020) · npj Vaccines · doi:10.1038/s41541-020-0163-z · Cited by 190 · see citing works
“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-citationNucleic 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 202 · see citing works
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 · see citing works
Eliciting B cell immunity against infectious diseases using nanovaccines
Singh, A. (2021) · Nature Nanotechnology · doi:10.1038/s41565-020-00790-3 · Cited by 169 · see citing works
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 170 · see citing works
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 167 · see citing works
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 · see citing works
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 171 · see citing works
“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 · see citing works
“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 · see citing works
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 152 · see citing works
Chatzikleanthous, D., O’Hagan, D. T., & Adamo, R. (2021) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.1c00447 · Cited by 150 · see citing works
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 137 · see citing works
“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 · see citing works
“…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 · see citing works
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 · see citing works
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 130 · see citing works
“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 127 · see citing works
“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 · see citing works
Kowalzik, F., Schreiner, D., Jensen, C., Teschner, D., Gehring, S., & Zepp, F. (2021) · Vaccines · doi:10.3390/vaccines9040390 · Cited by 127 · see citing works
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 121 · see citing works
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 120 · see citing works
“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 · see citing works
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 114 · see citing works
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 · see citing works
mRNA vaccines for COVID-19 and diverse diseases
Hussain, A., Yang, H., Zhang, M., Liu, Q., Alotaibi, G., Irfan, M. F., He, H., Chang, J. K., Liang, X., Weng, Y., et al. (2022) · Journal of Controlled Release · doi:10.1016/j.jconrel.2022.03.032 · Cited by 117 · see citing works
“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 · see citing works
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 111 · see citing works
Current Developments and Challenges of mRNA Vaccines
Chen, J., Chen, J., & Xu, Q. (2022) · Annual Review of Biomedical Engineering · doi:10.1146/annurev-bioeng-110220-031722 · Cited by 106 · see citing works
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 · see citing works
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 110 · see citing works
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 103 · see citing works
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 98 · see citing works
Garg, I., Shekhar, R., Sheikh, A. B., & Pal, S. (2021) · Infectious Disease Reports · doi:10.3390/idr13030064 · Cited by 99 · see citing works
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 96 · see citing works
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 97 · see citing works
“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 · see citing works
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 98 · see citing works
Engineering nanoparticle toolkits for mRNA delivery
Sun, B. F., 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 93 · see citing works
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 · see citing works
How COVID unlocked the power of RNA vaccines
Dolgin, E. (2021) · Nature · doi:10.1038/d41586-021-00019-w · Cited by 90 · see citing works
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 90 · see citing works
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 88 · see citing works
Li, X., Qi, J., Wang, J., Hu, W., Zhou, W., Wang, Y., & Li, T. (2024) · Theranostics · doi:10.7150/thno.84291 · Cited by 96 · see citing works
“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 · see citing works
Synthetic Messenger RNA-Based Vaccines: From Scorn to Hype
Pascolo, S. (2021) · Viruses · doi:10.3390/v13020270 · Cited by 86 · see citing works
“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
- 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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