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Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.
Anderson, Evan J; Rouphael, Nadine G; Widge, Alicia T; Jackson, Lisa A; Roberts, Paul C; Makhene, Mamodikoe; Chappell, James D; Denison, Mark R; Stevens, Laura J; Pruijssers, Andrea J; McDermott, Adrian B; Flach, Britta; Lin, Bob C; Doria-Rose, Nicole A; O'Dell, Sijy; Schmidt, Stephen D; Corbett, Kizzmekia S; Swanson, Phillip A; Padilla, Marcelino; Neuzil, Kathy M; Bennett, Hamilton; Leav, Brett; Makowski, Mat; Albert, Jim; Cross, Kaitlyn; Edara, Venkata Viswanadh; Floyd, Katharine; Suthar, Mehul S; Martinez, David R; Baric, Ralph; Buchanan, Wendy; Luke, Catherine J; Phadke, Varun K; Rostad, Christina A; Ledgerwood, Julie E; Graham, Barney S; Beigel, John H.
  • Anderson EJ; From 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.), Atlant
  • Rouphael NG; From 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.), Atlant
  • Widge AT; From 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.), Atlant
  • Jackson LA; From 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.), Atlant
  • Roberts PC; From 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.), Atlant
  • Makhene M; From 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.), Atlant
  • Chappell JD; From 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.), Atlant
  • Denison MR; From 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.), Atlant
  • Stevens LJ; From 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.), Atlant
  • Pruijssers AJ; From 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.), Atlant
  • McDermott AB; From 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.), Atlant
  • Flach B; From 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.), Atlant
  • Lin BC; From 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.), Atlant
  • Doria-Rose NA; From 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.), Atlant
  • O'Dell S; From 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.), Atlant
  • Schmidt SD; From 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.), Atlant
  • Corbett KS; From 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.), Atlant
  • Swanson PA; From 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.), Atlant
  • Padilla M; From 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.), Atlant
  • Neuzil KM; From 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.), Atlant
  • Bennett H; From 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.), Atlant
  • Leav B; From 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.), Atlant
  • Makowski M; From 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.), Atlant
  • Albert J; From 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.), Atlant
  • Cross K; From 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.), Atlant
  • Edara VV; From 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.), Atlant
  • Floyd K; From 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.), Atlant
  • Suthar MS; From 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.), Atlant
  • Martinez DR; From 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.), Atlant
  • Baric R; From 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.), Atlant
  • Buchanan W; From 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.), Atlant
  • Luke CJ; From 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.), Atlant
  • Phadke VK; From 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.), Atlant
  • Rostad CA; From 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.), Atlant
  • Ledgerwood JE; From 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.), Atlant
  • Graham BS; From 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.), Atlant
  • Beigel JH; From 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.), Atlant
N Engl J Med ; 383(25): 2427-2438, 2020 12 17.
Article in English | MEDLINE | ID: covidwho-811499
Semantic information from SemMedBD (by NLM)
1. Senility COEXISTS_WITH COVID-19
Subject
Senility
Predicate
COEXISTS_WITH
Object
COVID-19
2. 2019 novel coronavirus PROCESS_OF Older Population
Subject
2019 novel coronavirus
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PROCESS_OF
Object
Older Population
3. M Protei PART_OF C5203676
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M Protei
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PART_OF
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C5203676
4. Multiple interventional procedures METHOD_OF Secondary Immunization
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Multiple interventional procedures
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METHOD_OF
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Secondary Immunization
5. Antibody Formation PROCESS_OF Recipient
Subject
Antibody Formation
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PROCESS_OF
Object
Recipient
6. Vaccines INTERACTS_WITH T-helper cell type 1
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Vaccines
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INTERACTS_WITH
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T-helper cell type 1
7. Senility COEXISTS_WITH COVID-19
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Senility
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COVID-19
8. 2019 novel coronavirus PROCESS_OF Older Population
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2019 novel coronavirus
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9. M Protein, multiple myeloma PART_OF 2019 novel coronavirus
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ABSTRACT

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.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Randomized controlled trials Topics: Vaccines Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Randomized controlled trials Topics: Vaccines Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2020 Document Type: Article