Carol J Baker1, Marcia A Rench, Pamela McInnes. 1. Departments of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA. cbaker@bcm.tmc.edu
Abstract
AIM: To determine the safety and immunogenicity of group B streptococcal (GBS) type III CPS-TT conjugate vaccine in pregnant women. METHODS: Prospective, randomized (2:1, vaccine:placebo), double-blind, placebo-controlled trial in women at 30-32 weeks' gestation and their infants. Immune responses were measured with IgG-specific ELISA assays; killing of III GBS by 1- and 2-month infant sera was assessed by opsonophagocytosis. RESULTS: Immunization was well-tolerated; maternal and infant outcomes were similar in vaccine and placebo groups. III-TT conjugate elicited good levels of IgG to III CPS that were functionally active against type III GBS through age 2 months. CONCLUSION: Maternal immunization with GBS CPS-TT conjugates could prevent maternal, neonatal and young infant GBS disease.
RCT Entities:
AIM: To determine the safety and immunogenicity of group B streptococcal (GBS) type III CPS-TT conjugate vaccine in pregnant women. METHODS: Prospective, randomized (2:1, vaccine:placebo), double-blind, placebo-controlled trial in women at 30-32 weeks' gestation and their infants. Immune responses were measured with IgG-specific ELISA assays; killing of III GBS by 1- and 2-month infant sera was assessed by opsonophagocytosis. RESULTS: Immunization was well-tolerated; maternal and infant outcomes were similar in vaccine and placebo groups. III-TT conjugate elicited good levels of IgG to III CPS that were functionally active against type III GBS through age 2 months. CONCLUSION: Maternal immunization with GBSCPS-TT conjugates could prevent maternal, neonatal and young infantGBS disease.
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