Mariakani

Infections are a leading cause of newborn deaths, with Group B Streptococcus (GBS) being the primary cause of sepsis and bacterial meningitis in infants during their first 90 days of life. Researchers are preparing for late-phase clinical trials of GBS vaccines designed for pregnant women to protect their unborn babies. The PROTECT project supports medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform data collection and surveillance systems for GBS and other infections, aiming to improve vaccine trial readiness and vaccine safety monitoring in these regions. The study focuses on three main areas: establishing pregnancy exposure registries using electronic health records to track pregnancy and infant outcomes; developing sentinel site surveillance for laboratory-confirmed GBS infections in infants under 90 days old; and evaluating vaccine confidence among pregnant women and key community stakeholders. The project will develop tools and communication strategies to increase vaccine acceptance and participation in trials, strengthening healthcare systems for future vaccine delivery. Participants will include pregnant women, infants with confirmed GBS infections, and community stakeholders across the four countries. Researchers will collect and analyze health data, monitor infection rates, and assess attitudes toward vaccination. The study will track outcomes such as pregnancy and infant health, infection incidence, and vaccine confidence over multiple years, supporting ongoing safety monitoring and preparation for vaccine rollout through a coordinated network of maternal vaccine trial sites.