A US case-control study to estimate infant group B streptococcal disease serological thresholds of risk-reduction
Abstract
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.
Article Details
Authors (38)
Julia C. Rhodes
Rebecca Kahn
Shanna Bolcen
Nong Shang
Yunmi Chung
Monica M. Farley
Amber N. Britton
Ashley E. Moore
Stepy Thomas
Joelle Nadle
California Emerging Infections Program, Oakland
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
Adult and Child Center for Outcomes Research and Delivery Science, University of Colorado School of Medicine, Children’s Hospital Colorado, Aurora
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