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An mRNA Vaccine against SARS-CoV-2 - Preliminary Report.
Jackson, Lisa A; Anderson, Evan J; Rouphael, Nadine G; Roberts, Paul C; Makhene, Mamodikoe; Coler, Rhea N; McCullough, Michele P; Chappell, James D; Denison, Mark R; Stevens, Laura J; Pruijssers, Andrea J; McDermott, Adrian; Flach, Britta; Doria-Rose, Nicole A; Corbett, Kizzmekia S; Morabito, Kaitlyn M; O'Dell, Sijy; Schmidt, Stephen D; Swanson, Phillip A; Padilla, Marcelino; Mascola, John R; Neuzil, Kathleen M; Bennett, Hamilton; Sun, Wellington; Peters, Etza; Makowski, Mat; Albert, Jim; Cross, Kaitlyn; Buchanan, Wendy; Pikaart-Tautges, Rhonda; Ledgerwood, Julie E; Graham, Barney S; Beigel, John H.
  • Jackson LA; From 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 Healthca
  • Anderson EJ; From 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 Healthca
  • Rouphael NG; From 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 Healthca
  • Roberts PC; From 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 Healthca
  • Makhene M; From 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 Healthca
  • Coler RN; From 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 Healthca
  • McCullough MP; From 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 Healthca
  • Chappell JD; From 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 Healthca
  • Denison MR; From 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 Healthca
  • Stevens LJ; From 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 Healthca
  • Pruijssers AJ; From 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 Healthca
  • McDermott A; From 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 Healthca
  • Flach B; From 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 Healthca
  • Doria-Rose NA; From 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 Healthca
  • Corbett KS; From 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 Healthca
  • Morabito KM; From 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 Healthca
  • O'Dell S; From 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 Healthca
  • Schmidt SD; From 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 Healthca
  • Swanson PA; From 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 Healthca
  • Padilla M; From 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 Healthca
  • Mascola JR; From 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 Healthca
  • Neuzil KM; From 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 Healthca
  • Bennett H; From 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 Healthca
  • Sun W; From 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 Healthca
  • Peters E; From 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 Healthca
  • Makowski M; From 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 Healthca
  • Albert J; From 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 Healthca
  • Cross K; From 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 Healthca
  • Buchanan W; From 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 Healthca
  • Pikaart-Tautges R; From 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 Healthca
  • Ledgerwood JE; From 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 Healthca
  • Graham BS; From 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 Healthca
  • Beigel JH; From 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 Healthca
N Engl J Med ; 383(20): 1920-1931, 2020 11 12.
Article in English | MEDLINE | ID: covidwho-971502
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ABSTRACT

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).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / RNA, Messenger / Viral Vaccines / Coronavirus Infections / Pandemics / Spike Glycoprotein, Coronavirus Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Young adult 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: Pneumonia, Viral / RNA, Messenger / Viral Vaccines / Coronavirus Infections / Pandemics / Spike Glycoprotein, Coronavirus Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Young adult Language: English Journal: N Engl J Med Year: 2020 Document Type: Article