Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19

Spyros Chalkias (), Charles Harper, Keith Vrbicky, Stephen R. Walsh, Brandon Essink, Adam Brosz, Nichole McGhee, Joanne E. Tomassini, Xing Chen, Ying Chang, Andrea Sutherland, David C. Montefiori, Bethany Girard, Darin K. Edwards, Jing Feng, Honghong Zhou, Lindsey R. Baden, Jacqueline M. Miller and Rituparna Das
Additional contact information
Spyros Chalkias: Moderna, Inc.
Charles Harper: Meridian Clinical Research
Keith Vrbicky: Meridian Clinical Research
Stephen R. Walsh: Brigham and Women’s Hospital
Brandon Essink: Meridian Clinical Research
Adam Brosz: Meridian Clinical Research
Nichole McGhee: Moderna, Inc.
Joanne E. Tomassini: Moderna, Inc.
Xing Chen: Moderna, Inc.
Ying Chang: Moderna, Inc.
Andrea Sutherland: Moderna, Inc.
David C. Montefiori: Department of Surgery and Duke Human Vaccine Institute
Bethany Girard: Moderna, Inc.
Darin K. Edwards: Moderna, Inc.
Jing Feng: Moderna, Inc.
Honghong Zhou: Moderna, Inc.
Lindsey R. Baden: Brigham and Women’s Hospital
Jacqueline M. Miller: Moderna, Inc.
Rituparna Das: Moderna, Inc.

Nature Communications, 2023, vol. 14, issue 1, 1-7

Abstract: Abstract We previously presented day 29 interim safety and immunogenicity results from a phase 2/3 study (NCT04927065) comparing the Omicron-BA.1-containing bivalent vaccine mRNA-1273.214 (50-µg) to the 50-µg mRNA-1273 booster in adults who previously received the mRNA-1273 primary series (100-µg) and mRNA-1273 first booster (50-µg) dose. Primary endpoints were safety, non-inferiority of the neutralizing antibody (nAb) and seroresponse against Omicron BA.1, superiority of the nAb response against Omicron-BA.1, and non-inferiority of the nAb response against ancestral SARS-CoV-2 for second boosters of mRNA-1273.214 versus mRNA-1273 at days 29 and 91. The key secondary endpoint was the seroresponse difference of mRNA-1273.214 versus mRNA-1273 against ancestral SARS-CoV-2 at days 29 and day 91. Participants were sequentially enrolled and dosed with 50-µg of mRNA-1273 (n = 376) or mRNA-1273.214 (n = 437) as second booster doses. Here we present day 91 post-booster results. In participants with no pre-booster, severe acute respiratory syndrome coronavirus 2-infection (SARS-CoV-2), mRNA-1273.214 elicited Omicron-BA.1-nAb titers (95% confidence interval [CI]) that were significantly higher (964.4 [834.4-1114.7]) than those of mRNA-1273 (624.2 [533.1-730.9]) and similar to those of mRNA-1273 against ancestral SARS-CoV-2 at day 91. mRNA-1273.214 also induced higher binding antibody responses against Omicron BA.1 and alpha, gamma and delta variants than mRNA-1273. Safety profiles were similar for both vaccines. The Omicron-BA.1 bivalent vaccine improved antibody responses compared to mRNA-1273 through 90 days post-booster.

Date: 2023
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DOI: 10.1038/s41467-023-38892-w

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