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

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.

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Publication Details

Journal
Nature Communications
Published
2025-10-23
DOI
https://doi.org/10.1038/s41467-025-64324-y
Citations
3
Primary Topic
Neonatal and Maternal Infections
Type
article
Field-Weighted Citation Impact
5.64

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article

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

Sundaram A. Vishwanathan, Theresa Tran, Kristi R. Van Winden, Ashley E. Moore et al.
3 citations
Nature Communications
Neonatal and Maternal Infections
5.64
article

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

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

Abstract

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.

Nature CommunicationsVol. 16(1)
Centers for Disease Control and Prevention (US), New York State Department of Health (US), Colorado Department of Public Health and Environment (US), Oregon Health Authority (US), Kaiser Permanente (US), Johns Hopkins University (US), Emory University (US), National Center for Immunization and Respiratory Diseases (US), University of Rochester Medical Center (US), Yale University (US), Yale New Haven Health System (US), Epidemic Intelligence Service (US), University of Minnesota Medical Center (US), Connecticut Department of Public Health (US), Georgia Department of Public Health (US), Kaiser Permanente San Leandro Medical Center (US), Federal Senate (BR), University of Colorado Denver (US)
Bill and Melinda Gates Foundation, New York State Department of Health, State of Connecticut Department of Public Health, Yale University, Emory University, Colorado Department of Public Health and Environment, Johns Hopkins University, University of Rochester, Georgia Department of Public Health, Centers for Disease Control and Prevention Foundation, Centers for Disease Control and Prevention, School of Medicine, Emory University, Johns Hopkins Bloomberg School of Public Health, Medical Center, University of Rochester
Openalex Percentile: Top 4%
Neonatal and Maternal Infections
5.64
DOIOpen Access PDFOpenAlex
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