Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates
Open accessAbstract
BACKGROUND: Vaccines to prevent coronavirus disease 2019 (Covid-19) are urgently needed. The effect of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines on viral replication in both upper and lower airways is important to evaluate in nonhuman primates. METHODS: Nonhuman primates received 10 or 100 μg of mRNA-1273, a vaccine encoding the prefusion-stabilized spike protein of SARS-CoV-2, or no vaccine. Antibody and T-cell responses were assessed before upper- and lower-airway challenge with SARS-CoV-2. Active viral replication and viral genomes in bronchoalveolar-lavage (BAL) fluid and nasal swab specimens were assessed by polymerase chain reaction, and histopathological analysis and viral quantification were performed on lung-tissue specimens. RESULTS: ) geometric mean titers of 501 in the 10-μg dose group and 3481 in the 100-μg dose group. Vaccination induced type 1 helper T-cell (Th1)-biased CD4 T-cell responses and low or undetectable Th2 or CD8 T-cell responses. Viral replication was not detectable in BAL fluid by day 2 after challenge in seven of eight animals in both vaccinated groups. No viral replication was detectable in the nose of any of the eight animals in the 100-μg dose group by day 2 after challenge, and limited inflammation or detectable viral genome or antigen was noted in lungs of animals in either vaccine group. CONCLUSIONS: Vaccination of nonhuman primates with mRNA-1273 induced robust SARS-CoV-2 neutralizing activity, rapid protection in the upper and lower airways, and no pathologic changes in the lung. (Funded by the National Institutes of Health and others.).
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The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion-stabilized full-length spike protein of SARS-CoV-2.
“The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19.”
From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [14]
The Methods section, “Vaccine mRNA and Lipid Nanoparticle Production” (page unavailable), says the vaccine mRNA encodes prefusion-stabilized SARS-CoV-2 S-2P protein and is encapsulated in a lipid nanoparticle. Our copy does not explicitly establish that the encoded spike protein is full-length; its use of “full-length” elsewhere refers to the virus used in a neutralization assay, not the vaccine antigen. (LLM, conf=0.78)
Experimental — accuracy not yet measuredAll U nucleotides were replaced by N1-methylpseudouridine (Ψ) in the vaccines.
“As mammalian host cells attack unmodified exogeneous RNA [12,13], all U nucleotides were replaced by N1-methylpseudouridine (Ψ) [14,15].”
From Detailed Dissection and Critical Evaluation of the Pfizer/BioNTech and Moderna mRNA Vaccines (2021) · cites this paper as [15]
The Discussion (page not provided) says nucleoside modifications can reduce innate immune stimulation, and the Methods describe the vaccine mRNA. Neither passage specifies that every U nucleotide in mRNA-1273 was replaced with N1-methylpseudouridine. (LLM, conf=0.80)
Experimental — accuracy not yet measuredPreclinical testing of mRNA-1273 and other SARS-CoV-2 vaccines in advanced clinical evaluation has shown a Th1-skewed vaccine response and no pathologic lung infiltrates.
“Of note, preclinical testing of mRNA-1273 and other SARS-CoV-2 vaccines in advanced clinical evaluation has shown a Th1-skewed vaccine response and no pathologic lung infiltrates. 15,26-28”
From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [15]
The mRNA-1273 vaccine demonstrated protection in animal-challenge experiments and encouraging safety and immunogenicity in early-stage human testing.
“The mRNA-1273 vaccine demonstrated protection in animal-challenge experiments 15 and encouraging safety and immunogenicity in early-stage human testing. 1,4”
From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [15]
Neutralizing antibody titres induced by CV2CoV in this study appear similar to those reported for other mRNA vaccines in macaques.
“The neutralizing antibody titres induced by CV2CoV in this study also appear to be similar to those reported for other mRNA vaccines in macaques27,28.”
From Optimization of non-coding regions for a non-modified mRNA COVID-19 vaccine (2022) · cites this paper as [27]
Vaccinees had significantly higher IgG and IgM than convalescent patients tested 1.3 and 6.2 months after infection; IgA was comparable.
“In line with previous reports3,6,9, IgG and IgM levels were significantly higher in the vaccinated group compared to a cohort of convalescent patients assayed 1.3 and 6.2 months after infection, while IgA levels were similar (Extended Data Fig 1j–l).”
From mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants (2021) · cites this paper as [9]
Neutralizing activity in plasma varied widely 3-14 weeks after the second dose; it resembled that in convalescent individuals at 1.3 months and exceeded that at 6.2 months.
“In agreement with previous reports3,6,9, there was a broad range of plasma neutralizing activity 3–14 weeks after the second vaccine dose that was similar to that elicited by natural infection in a convalescent cohort after 1.3 months, and greater than the activity at 6.2 months after infection (Fig. 1a, Extended Data Table 1).”
From mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants (2021) · cites this paper as [9]
Several nonhuman primate COVID-19 vaccine studies are consistent with the possibility that COVID-19 vaccines prevent severe disease in humans but may not prevent upper respiratory tract infection.
“Several non-human primate COVID-19 vaccine studies are consistent with the possibility of COVDI-19 vaccines preventing severe disease in humans but possibly not preventing URT infection”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Corbett et al., 2020
Multiple major candidate vaccines had efficacy at short-term protection in pre-clinical models, including the J&J Ad26 vector-based vaccine.
“Multiple major candidate vaccines had efficacy at short-term protection in pre-clinical models, including the J&J Ad26 vector-based vaccine”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Corbett et al., 2020
Th1 and Tfh cell responses were elicited by the Moderna/VRC RNA vaccine.
“Th1 and Tfh cell response were elicited to the Moderna/VRC RNA vaccine”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Corbett et al., 2020
mRNA-1273 vaccination induces TH1- and TFH-skewed CD4 T cell responses.
“Thus, in agreement with previous results (13, 25, 26), mRNA-1273 vaccination induces TH1- and TFH-skewed CD4 T cell responses.”
From Immune correlates of protection by mRNA-1273 vaccine against SARS-CoV-2 in nonhuman primates (2021) · cites this paper as [13]
Vaccinated macaques elicited spike protein-specific IgG and IgA antibodies in nasal washes and bronchoalveolar lavages.
“Vaccinated macaques also elicited spike protein-specific IgG and IgA antibodies in nasal washes and bronchoalveolar lavages, suggesting that intramuscular vaccination with mRNA-1273 confers both serum and mucosal immunity128,129.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [128]
Intramuscular vaccination with mRNA-1273 confers both serum and mucosal immunity.
“suggesting that intramuscular vaccination with mRNA-1273 confers both serum and mucosal immunity128,129.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [128]
Rhesus macaques that received two 100 μg doses of mRNA-1273 developed potent humoral and cellular immune responses.
“Rhesus macaques that received two 100 μg doses of the vaccine also developed potent humoral and cellular immune responses128.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [128]
Compared with serum from patients recovering from COVID-19, vaccinated macaque serum contained 15-fold higher titres of neutralizing antibodies, 348-fold more potent inhibitory activity for spike binding to angiotensin-converting enzyme 2 and 12-fold higher virus-neutralizing activity.
“In comparison with serum from patients recovering from COVID-19, vaccinated macaque serum contained 15-fold higher titres of neutralizing antibodies, 348-fold more potent inhibitory activity for spike binding to the angiotensin-converting enzyme 2 and 12-fold higher virus-neutralizing activity128.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [128]
In non-human primate viral challenge experiments, both mRNA vaccines produced rapid viral control in the upper and lower airways.
“Supported by evidence obtained in viral challenge experiments in non-human primates that both vaccines produced rapid viral control in the upper and lower airways”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [52]
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Self-citation
- Authors
- Corbett, K. S., Flynn, B., Foulds, K. E., Francica, J. R., Boyoglu-Barnum, S., Werner, A. P., Flach, B., O’Connell, S., Bock, K. W., Minai, M., Nagata, B. M., Andersen, H., Martinez, D. R., Noe, A. T., Douek, N., Donaldson, M. M., Nji, N. N., Alvarado, G. S., Edwards, D. K., Flebbe, D. R., Lamb, E., Doria-Rose, N. A., Lin, B. C., Louder, M. K., O’Dell, S., Schmidt, S. D., Phung, E., Chang, L. A., Yap, C., Todd, J.-P. M., Pessaint, L., Van Ry, A., Browne, S., Greenhouse, J., Putman-Taylor, T., Strasbaugh, A., Campbell, T.-A., Cook, A., Dodson, A., Steingrebe, K., Shi, W., Zhang, Y., Abiona, O. M., Wang, L., Pegu, A., Yang, E. S., Leung, K., Zhou, T., Teng, I.-T., Widge, A., Gordon, I., Novik, L., Gillespie, R. A., Loomis, R. J., Moliva, J. I., Stewart-Jones, G., Himansu, S., Kong, W.-P., Nason, M. C., Morabito, K. M., Ruckwardt, T. J., Ledgerwood, J. E., Gaudinski, M. R., Kwong, P. D., Mascola, J. R., Carfi, A., Lewis, M. G., Baric, R. S., McDermott, A., Moore, I. N., Sullivan, N. J., Roederer, M., Seder, R. A., & Graham, B. S.
- Affiliations
- George Washington University (US)
- From the Vaccine Research Center (K.S.C., B. Flynn, K.E.F., J.R.F., S.B.-B., A.P.W., B. Flach, S. O’Connell, A.T.N., N.D., M.M.D., N.N.N., G.S.A., D.R.F., E.L., N.A.D.-R., B.C.L., M.K.L., S. O’Dell, S.D.S., E.P., L.A.C., C.Y., J.-P.M.T., W.S., Y.Z., O.M.A., L.W., A.P., E.S.Y., K.L., T.Z., I.-T.T., A.W., I.G., L.N., R.A.G., R.J.L., J.I.M., W.-P.K., K.M.M., T.J.R., J.E.L., M.R.G., P.D.K., J.R.M., A.M., N.J.S., M.R., R.A.S., B.S.G.), the Infectious Disease Pathogenesis Section (K.W.B., M.M., B.M.N., M...
- Corresponding author
- Graham, Barney S.
- ORCID
- Corbett, Kizzmekia S.
- Flynn, Barbara
- Foulds, Kathryn E.
- Francica, Joseph R.
- Werner, Anne P.
- O’Connell, Sarah
- Bock, Kevin W.
- Minai, Mahnaz
- Nagata, Bianca M.
- Andersen, Hanne
- Martinez, David R.
- Noe, Amy T.
- Alvarado, Gabriela S.
- Edwards, Darin K.
- Lamb, Evan
- Doria-Rose, Nicole A.
- Lin, Bob C.
- Louder, Mark K.
- Schmidt, Stephen D.
- Phung, Emily
- Chang, Lauren A.
- Todd, John-Paul M.
- Pessaint, Laurent
- Van Ry, Alex
- Greenhouse, Jack
- Putman-Taylor, Tammy
- Strasbaugh, Amanda
- Campbell, Tracey-Ann
- Cook, Anthony
- Dodson, Alan
- Steingrebe, Katelyn
- Shi, Wei
- Zhang, Yi
- Abiona, Olubukola M.
- Wang, Lingshu
- Pegu, Amarendra
- Yang, Eun Sung
- Leung, Kwanyee
- Zhou, Tongqing
- Teng, I-Ting
- Widge, Alicia
- Gordon, Ingelise
- Novik, Laura
- Gillespie, Rebecca A.
- Loomis, Rebecca J.
- Moliva, Juan I.
- Stewart-Jones, Guillaume
- Himansu, Sunny
- Kong, Wing-Pui
- Nason, Martha C.
- Morabito, Kaitlyn M.
- Ruckwardt, Tracy J.
- Ledgerwood, Julie E.
- Gaudinski, Martin R.
- Kwong, Peter D.
- Mascola, John R.
- Lewis, Mark G.
- Baric, Ralph S.
- McDermott, Adrian
- Moore, Ian N.
- Sullivan, Nancy J.
- Roederer, Mario
- Seder, Robert A.
- Graham, Barney S.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-10-15
- Volume
- 383
- Issue
- 16
- Pages
- 1544-1555
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7449230
- OpenAlex
- W3046061621
- Cited by
- 1,066
- References
- 46
- Citations by year
- 2026: 38 · 2025: 57 · 2024: 84 · 2023: 105 · 2022: 246 · 2021: 438 · 2020: 95 · 2013: 1
- FWCI
- 29.10
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- UNC Libraries
- Funders
- National Institutes of Health (1f32ai152296-01a1)
- National Institute of Allergy and Infectious Diseases (F32 AI152296, T32AI007151)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Agricultural and Biological Sciences › Animal Science and Zoology › Animal Virus Infections Studies
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- mRNA-1273 vaccine, SARS-CoV-2, COVID-19 vaccines, non-human primates, neutralizing antibodies, bronchoalveolar lavage, lung histopathology, vaccine dose comparison
- MeSH terms
- Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, COVID-19 Serotherapy, Animals, Antibodies, Viral, Disease Models, Animal, Dose-Response Relationship, Immunologic, Immunization, Passive, Lung, Macaca mulatta, Pneumonia, Viral, T-Lymphocytes, Viral Vaccines, Virus Replication, CD4 Antigens, Coronavirus Infections, Viral Load, Antibodies, Neutralizing, Pandemics, Spike Glycoprotein, Coronavirus
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