Preparing for Phase IIIIV Maternal Group B Streptococcus Vaccine Trials and Surveillance in Africa Building Pregnancy Registries, Infant Infection Monitoring, and Vaccine Confidence

What this Trial Is About

Group B Streptococcus GBS is a leading cause of sepsis and bacterial meningitis in newborns during the first 90 days of life, contributing significantly to newborn deaths. Researchers are preparing for maternal GBS vaccine trials in Africa to improve infection prevention through better data collection, surveillance, and vaccine confidence. The PROTECT project supports sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data, monitor GBS incidence, and understand factors affecting vaccine acceptance. The study consists of three main parts creating pregnancy exposure registries using electronic health records to track pregnancy and infant outcomes conducting a prospective observational GBS surveillance study among infants under 90 days with confirmed GBS infection at sentinel sites and assessing vaccine confidence through surveys and interviews with pregnant women, healthcare workers, and community leaders. These activities aim to strengthen healthcare systems for future vaccine trials and rollout. Participants include pregnant women and their infants up to hospital discharge for the registry infants under 90 days with confirmed GBS infection for surveillance and pregnant women, healthcare workers, and community stakeholders for vaccine confidence research. The study involves collecting and analyzing medical records, microbiological data, and survey responses over periods ranging from 12 months to two years. Researchers will monitor pregnancy and infant outcomes, GBS infection rates, and vaccine knowledge to prepare for vaccine safety monitoring and effective vaccine implementation.

Preparing for Maternal GBS Vaccine Trials in Africa