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A Bivalent Omicron-Containing Booster Vaccine against Covid-19.
Chalkias, Spyros; Harper, Charles; Vrbicky, Keith; Walsh, Stephen R; Essink, Brandon; Brosz, Adam; McGhee, Nichole; Tomassini, Joanne E; Chen, Xing; Chang, Ying; Sutherland, Andrea; Montefiori, David C; Girard, Bethany; Edwards, Darin K; Feng, Jing; Zhou, Honghong; Baden, Lindsey R; Miller, Jacqueline M; Das, Rituparna.
  • Chalkias S; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Harper C; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Vrbicky K; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Walsh SR; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Essink B; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Brosz A; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • McGhee N; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Tomassini JE; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Chen X; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Chang Y; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Sutherland A; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Montefiori DC; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Girard B; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Edwards DK; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Feng J; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Zhou H; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Baden LR; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Miller JM; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
  • Das R; From Moderna, Cambridge (S.C., N.M., J.E.T., X.C., Y.C., A.S., B.G., D.K.E., J.F., H.Z., J.M.M., R.D.), and Brigham and Women's Hospital, Boston (S.R.W., L.R.B.) - both in Massachusetts; Meridian Clinical Research, Norfolk (C.H., K.V.), Meridian Clinical Research, Omaha (B.E.), and Meridian Clinical
N Engl J Med ; 387(14): 1279-1291, 2022 10 06.
Article in English | MEDLINE | ID: covidwho-2036976
ABSTRACT

BACKGROUND:

The safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known.

METHODS:

In this ongoing, phase 2-3 study, we compared the 50-µg bivalent vaccine mRNA-1273.214 (25 µg each of ancestral Wuhan-Hu-1 and omicron B.1.1.529 [BA.1] spike messenger RNAs) with the previously authorized 50-µg mRNA-1273 booster. We administered mRNA-1273.214 or mRNA-1273 as a second booster in adults who had previously received a two-dose (100-µg) primary series and first booster (50-µg) dose of mRNA-1273 (≥3 months earlier). The primary objectives were to assess the safety, reactogenicity, and immunogenicity of mRNA-1273.214 at 28 days after the booster dose.

RESULTS:

Interim results are presented. Sequential groups of participants received 50 µg of mRNA-1273.214 (437 participants) or mRNA-1273 (377 participants) as a second booster dose. The median time between the first and second boosters was similar for mRNA-1273.214 (136 days) and mRNA-1273 (134 days). In participants with no previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the geometric mean titers of neutralizing antibodies against the omicron BA.1 variant were 2372.4 (95% confidence interval [CI], 2070.6 to 2718.2) after receipt of the mRNA-1273.214 booster and 1473.5 (95% CI, 1270.8 to 1708.4) after receipt of the mRNA-1273 booster. In addition, 50-µg mRNA-1273.214 and 50-µg mRNA-1273 elicited geometric mean titers of 727.4 (95% CI, 632.8 to 836.1) and 492.1 (95% CI, 431.1 to 561.9), respectively, against omicron BA.4 and BA.5 (BA.4/5), and the mRNA-1273.214 booster also elicited higher binding antibody responses against multiple other variants (alpha, beta, gamma, and delta) than the mRNA-1273 booster. Safety and reactogenicity were similar with the two booster vaccines. Vaccine effectiveness was not assessed in this study; in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster.

CONCLUSIONS:

The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Vaccines, Combined / COVID-19 Vaccines / COVID-19 / MRNA Vaccines Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Vaccines, Combined / COVID-19 Vaccines / COVID-19 / MRNA Vaccines Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article