TY - JOUR
T1 - A US case-control study to estimate infant group B streptococcal disease serological thresholds of risk-reduction
AU - Rhodes, Julia C.
AU - Kahn, Rebecca
AU - Bolcen, Shanna
AU - Shang, Nong
AU - Chung, Yunmi
AU - Farley, Monica M.
AU - Britton, Amber N.
AU - Moore, Ashley E.
AU - Thomas, Stepy
AU - Nadle, Joelle
AU - Amsden, Laura B.
AU - Skarbinski, Jacek
AU - VanWinden, Kristi R.
AU - Barnes, Meghan
AU - Engesser, Kerianne
AU - Ferrieri, Patricia
AU - Hansen, Amber Jean P.
AU - Harrison, Lee H.
AU - Jeffrey, Laura
AU - Nyholm, Jessica L.
AU - O’Leary, Sean T.
AU - Olson-Chen, Courtney
AU - Rowlands, Jemma V.
AU - Seopaul, Shannon A.
AU - Thomas, Ann R.
AU - Wrigley, Htet Htet N.
AU - McGee, Lesley
AU - Vishwanathan, Sundaram Ajay
AU - Akhter, Fahmina
AU - Alston, Bailey
AU - Jia, Lily Tao
AU - Li, Yikun
AU - Patel, Palak Y.
AU - Rivers, Joy
AU - Southwell, Jessica E.
AU - Tran, Theresa
AU - Maniatis, Panagiotis
AU - Schrag, Stephanie J.
N1 - Publisher Copyright:
© This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2025.
PY - 2025/12
Y1 - 2025/12
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/105019530448
UR - https://www.scopus.com/pages/publications/105019530448#tab=citedBy
U2 - 10.1038/s41467-025-64324-y
DO - 10.1038/s41467-025-64324-y
M3 - Article
C2 - 41130982
AN - SCOPUS:105019530448
SN - 2041-1723
VL - 16
JO - Nature communications
JF - Nature communications
IS - 1
M1 - 9381
ER -