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Lisa A. Jackson, M.D., M.P.H.,
Evan J. Anderson, M.D.,
Nadine G. Rouphael, M.D.,
Paul C. Roberts, Ph.D.,
Mamodikoe Makhene, M.D., M.P.H.,
Rhea N. Coler, Ph.D.,
Michele P. McCullough, M.P.H.,
James D. Chappell, M.D., Ph.D.,
Mark R. Denison, M.D.,
Laura J. Stevens, M.S.,
Andrea J. Pruijssers, Ph.D.,
Adrian McDermott, Ph.D.,
et al., for the mRNA-1273 Study Group
July 14, 2020
DOI: 10.1056/NEJMoa2022483
...
RESULTS
After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.
CONCLUSIONS
The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461. opens in new tab).
Evan J. Anderson, M.D.,
Nadine G. Rouphael, M.D.,
Paul C. Roberts, Ph.D.,
Mamodikoe Makhene, M.D., M.P.H.,
Rhea N. Coler, Ph.D.,
Michele P. McCullough, M.P.H.,
James D. Chappell, M.D., Ph.D.,
Mark R. Denison, M.D.,
Laura J. Stevens, M.S.,
Andrea J. Pruijssers, Ph.D.,
Adrian McDermott, Ph.D.,
et al., for the mRNA-1273 Study Group
July 14, 2020
DOI: 10.1056/NEJMoa2022483
...
RESULTS
After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.
CONCLUSIONS
The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461. opens in new tab).
