An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Lisa A. JacksonFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inEvan J. AndersonFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inNadine RouphaelFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inPaul C. RobertsFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inMamodikoe MakheneFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inRhea N. ColerFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inMichele Paine McCulloughFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inJames D. ChappellFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inMark R. DenisonFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inLaura J. StevensFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inAndrea J. PruijssersFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inAdrian B. McDermottFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inBritta FlachFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inNicole A. Doria‐RoseFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inKizzmekia S. CorbettFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inKaitlyn M. MorabitoFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inSijy O’DellFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inStephen D. SchmidtFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inPhillip A. SwansonFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inMarcelino PadillaFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inJohn R. MascolaFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inKathleen M. NeuzilFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inHamilton BennettFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inWellington SunFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inEtza PetersFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inMat MakowskiFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inJim AlbertFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inKaitlyn CrossFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inWendy BuchananFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inRhonda Pikaart-TautgesFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inJulie E. LedgerwoodFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inBarney S. GrahamFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both inJohn H. BeigelFrom Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both in
2020en
ABI
Аннотация
BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. METHODS: We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. 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).
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