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

Author

Listed:
  • 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.)

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.

Suggested Citation

  • 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. Montefi, 2023. "Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19," Nature Communications, Nature, vol. 14(1), pages 1-7, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-38892-w
    DOI: 10.1038/s41467-023-38892-w
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    1. Yunlong Cao & Ayijiang Yisimayi & Fanchong Jian & Weiliang Song & Tianhe Xiao & Lei Wang & Shuo Du & Jing Wang & Qianqian Li & Xiaosu Chen & Yuanling Yu & Peng Wang & Zhiying Zhang & Pulan Liu & Ran A, 2022. "BA.2.12.1, BA.4 and BA.5 escape antibodies elicited by Omicron infection," Nature, Nature, vol. 608(7923), pages 593-602, August.
    2. Wafaa B. Alsoussi & Sameer Kumar Malladi & Julian Q. Zhou & Zhuoming Liu & Baoling Ying & Wooseob Kim & Aaron J. Schmitz & Tingting Lei & Stephen C. Horvath & Alexandria J. Sturtz & Katherine M. McInt, 2023. "SARS-CoV-2 Omicron boosting induces de novo B cell response in humans," Nature, Nature, vol. 617(7961), pages 592-598, May.
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    1. Lindsey R. Baden & Hana M. El Sahly & Brandon Essink & Dean Follmann & Gregory Hachigian & Cynthia Strout & J. Scott Overcash & Susanne Doblecki-Lewis & Jennifer A. Whitaker & Evan J. Anderson & Kathl, 2024. "Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases," Nature Communications, Nature, vol. 15(1), pages 1-13, December.

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