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<p>Maternal vaccines to prevent infant Group B <i>Streptococcus</i> (GBS) disease have progressed through phase II development and may be licensed based on immunologic endpoints, which have yet to be approved by regulatory authorities. Here we present a multistate case control study to characterize the relationship between serotype-specific anti-capsular polysaccharide (CPS) immunoglobulin G concentrations near birth and infant GBS disease risk reduction. Antibody concentration distributions are significantly lower for cases (n = 643) than controls (n = 2801) and serologic thresholds varied by serotype and age at onset, with 80% serotype-specific protective thresholds ranging from 0.52 to 2.49 mcg/mL for early-onset disease (EOD; &lt;7 days old) and 0.02 to 0.14 mcg/mL for late-onset disease (LOD; 7-89 days old). Our study provides the most robust data to date that protection thresholds vary by serotype and are notably lower for LOD than EOD, thereby informing potential serological endpoints for phase III trials evaluating CPS-based maternal GBS vaccine candidates.</p>

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A US case-control study to estimate infant group B streptococcal disease serological thresholds of risk-reduction

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月23日

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  • Julia C. Rhodes,
  • Rebecca Kahn,
  • Shanna Bolcen,
  • Nong Shang,
  • Yunmi Chung,
  • Monica M. Farley,
  • Amber N. Britton,
  • Ashley E. Moore,
  • Stepy Thomas,
  • Joelle Nadle,
  • Laura B. Amsden,
  • Jacek Skarbinski,
  • Kristi R. VanWinden,
  • Meghan Barnes,
  • Kerianne Engesser,
  • Patricia Ferrieri,
  • AmberJean P. Hansen,
  • Lee H. Harrison,
  • Laura Jeffrey,
  • Jessica L. Nyholm,
  • Sean T. O’Leary,
  • Courtney Olson-Chen,
  • Jemma V. Rowlands,
  • Shannon A. Seopaul,
  • Ann R. Thomas,
  • Htet Htet N. Wrigley,
  • Lesley McGee,
  • Sundaram Ajay Vishwanathan,
  • Fahmina Akhter,
  • Bailey Alston,
  • Lily Tao Jia,
  • Yikun Li,
  • Palak Y. Patel,
  • Joy Rivers,
  • Jessica E. Southwell,
  • Theresa Tran,
  • Panagiotis Maniatis,
  • Stephanie J. Schrag

摘要

Maternal vaccines to prevent infant Group B Streptococcus (GBS) disease have progressed through phase II development and may be licensed based on immunologic endpoints, which have yet to be approved by regulatory authorities. Here we present a multistate case control study to characterize the relationship between serotype-specific anti-capsular polysaccharide (CPS) immunoglobulin G concentrations near birth and infant GBS disease risk reduction. Antibody concentration distributions are significantly lower for cases (n = 643) than controls (n = 2801) and serologic thresholds varied by serotype and age at onset, with 80% serotype-specific protective thresholds ranging from 0.52 to 2.49 mcg/mL for early-onset disease (EOD; <7 days old) and 0.02 to 0.14 mcg/mL for late-onset disease (LOD; 7-89 days old). Our study provides the most robust data to date that protection thresholds vary by serotype and are notably lower for LOD than EOD, thereby informing potential serological endpoints for phase III trials evaluating CPS-based maternal GBS vaccine candidates.