Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Evan J. AndersonFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SNadine RouphaelFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SAlicia T. WidgeFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SLisa A. JacksonFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SPaul C. RobertsFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SMamodikoe MakheneFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SJames D. ChappellFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SMark R. DenisonFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SLaura J. StevensFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SAndrea J. PruijssersFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SAdrian B. McDermottFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SBritta FlachFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SBob C. LinFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SNicole A. Doria‐RoseFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SSijy O’DellFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SStephen D. SchmidtFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SKizzmekia S. CorbettFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SPhillip A. SwansonFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SMarcelino PadillaFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SKathy M. NeuzilFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SHamilton BennettFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SBrett LeavFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SMat MakowskiFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SJim AlbertFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SKaitlyn CrossFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SVenkata Viswanadh EdaraFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SKatharine FloydFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SMehul S. SutharFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SDavid MartínezFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SRalph S. BaricFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SWendy BuchananFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SCatherine J. LukeFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SVarun K. PhadkeFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SChristina A. RostadCenter for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of MedicineJulie E. LedgerwoodFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SBarney S. GrahamFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., SJohn H. BeigelFrom the Center for Childhood Infections and Vaccines of Children’s Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (E.J.A., V.V.E., K.F., M.S.S., C.A.R.), and Emory Vaccine Center, Yerkes National Primate Research Center, Emory University (M.S.S.), Atlanta, and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (E.J.A., N.G.R., V.K.P.) — both in Georgia; the Vaccine Research Center (A.T.W., A.B.M., B.F., B.C.L., N.A.D.-R., S
2020en
ABI
Аннотация
BACKGROUND: Testing of vaccine candidates to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in an older population is important, since increased incidences of illness and death from coronavirus disease 2019 (Covid-19) have been associated with an older age. METHODS: We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in healthy adults. The trial was expanded to include 40 older adults, who were stratified according to age (56 to 70 years or ≥71 years). All the participants were assigned sequentially to receive two doses of either 25 μg or 100 μg of vaccine administered 28 days apart. RESULTS: Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti-S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods. Binding- and neutralizing-antibody responses appeared to be similar to those previously reported among vaccine recipients between the ages of 18 and 55 years and were above the median of a panel of controls who had donated convalescent serum. The vaccine elicited a strong CD4 cytokine response involving type 1 helper T cells. CONCLUSIONS: In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461.).
Перевод пока недоступен
Идентификаторы
Цитирования и источники
Цитирований: 2Использованных источников: 0