The immunogenicity, reactogenicity, and safety of a bivalent mRNA or protein COVID-19 vaccine given as a fourth dose.

• Tác giả: Kathryn Bright, Shashini Dassanayake, Lien Anh Ha Do, John Hart, Rachel A Higgins, Fran Justice, Paul V Licciardi, Skyy Luu, Siddhartha Mahanty, Nadia Mazarakis, Claire von Mollendorf, Kerryn A Moore, Kim Mulholland, Eleanor Neal, Yan Yung Ng, Cattram Nguyen, Darren Suryawijaya Ong, Leanne Quah, Anna Rudel, Kanta Subbarao, Zheng Quan Toh, Emma Watts
• Ngôn ngữ: eng
• Ký hiệu phân loại: 571.9648 Diseases Pathology
• Thông tin xuất bản: England : The Journal of infection , 2025
• Bộ sưu tập: NCBI
• ID: 224325

Tóm tắt

 OBJECTIVES: We conducted a randomised controlled trial (RCT) to compare immunogenicity, reactogenicity and safety one month after a fourth COVID-19 mRNA or protein vaccine dose. METHODS: This RCT recruited healthy adults in Melbourne, Australia, who had previously received three COVID-19 vaccine doses at least six months prior and had no SARS-CoV-2 infection in the last three months. The participants were randomised (1:1) to receive the bivalent mRNA vaccine (mRNA-1273.214/mRNA-1273.222, hereafter Moderna) or protein vaccine (NVX-CoV-2373, hereafter Novavax) as a fourth dose. A self-selected control group who elected not to receive an additional dose were also included. The co-primary endpoints compared immunogenicity at 28 days post-vaccination measured as binding antibodies (IgG against Ancestral and Omicron subvariants
  BA.1, BA.4/5 and JN.1) between the two vaccine groups, and reactogenicity within one-week post-vaccination. CLINICALTRIALS: gov Identifier: NCT05543356. RESULTS: Between Feb 28 and Oct 4, 2023, 496 participants were enrolled into the study. Participants were randomised into either the bivalent mRNA Moderna (n=177) or protein Novavax (n=176) vaccine groups, with n=143 allocated to the control group. The geometric mean ratio (GMR) of anti-Spike binding IgG antibody levels were higher for the Moderna vaccine compared to the Novavax vaccine at 28 days post-vaccination for all variants tested, including Ancestral (GMR: 2.11, 95% CI: 1.88 - 2.37), BA.1 (GMR: 2.32, 95% CI 2.04 - 2.63), BA.4/5 (GMR: 2.32, 95% CI: 2.04 - 2.65), and JN.1 (GMR: 2.40, 95% CI: 2.14 - 2.70). The frequency of any local and systemic reactions (grades 1-4) was higher for the Moderna vaccine (159/177
  89.8%) compared to the Novavax vaccine (130/176
  73.9%). Serious reactions (grade 3-4) between the groups were similar (11/177
  6.2%, versus 9/176
  5.1%, respectively). CONCLUSION: At day 28 post-vaccination, higher immunogenicity was observed following Moderna vaccination compared to Novavax vaccination when given as a fourth dose in healthy adults for Ancestral and Omicron subvariants, including JN.1. However, local and systemic reactogenicity was higher in the Moderna vaccine group compared with the Novavax vaccine group. These results may have important implications for ongoing booster strategies.