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

IF 15.7 1区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

Nature Communications Pub Date : 2025-10-23 DOI:10.1038/s41467-025-64324-y

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

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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.

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一项美国病例对照研究估计婴儿B组链球菌病的血清学阈值的风险降低。

预防婴儿B群链球菌（GBS）疾病的母源疫苗已通过II期开发，可能会根据免疫终点获得许可，但尚未获得监管机构的批准。在这里，我们提出了一项多状态病例对照研究，以表征出生时血清型特异性抗荚膜多糖（CPS）免疫球蛋白G浓度与婴儿GBS疾病风险降低之间的关系。病例（n = 643）的抗体浓度分布明显低于对照组（n = 2801），血清阈值因血清型和发病年龄而异，80%血清型特异性保护阈值在早发性疾病（EOD, <7天龄）的0.52 - 2.49 mcg/mL和晚发性疾病（LOD， 7-89天龄）的0.02 - 0.14 mcg/mL之间。我们的研究提供了迄今为止最可靠的数据，即保护阈值因血清型而异，LOD的保护阈值明显低于EOD，从而为评估基于cps的母体GBS候选疫苗的III期试验提供了潜在的血清学终点。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nature Communications Biological Science Disciplines-

CiteScore

24.90

自引率

2.40%

发文量

6928

审稿时长

3.7 months

期刊介绍： Nature Communications, an open-access journal, publishes high-quality research spanning all areas of the natural sciences. Papers featured in the journal showcase significant advances relevant to specialists in each respective field. With a 2-year impact factor of 16.6 (2022) and a median time of 8 days from submission to the first editorial decision, Nature Communications is committed to rapid dissemination of research findings. As a multidisciplinary journal, it welcomes contributions from biological, health, physical, chemical, Earth, social, mathematical, applied, and engineering sciences, aiming to highlight important breakthroughs within each domain.