Preparing for Maternal GBS Vaccine Trials in Africa

Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life. Fortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths. The PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting systems, medical sites can participate in vaccine trials and monitor vaccine safety. At the same time, the consortium is working to understand the drivers of vaccine hesitancy and to develop culturally appropriate communication tools to facilitate engagement with vaccines. The end goal is to set up a network of sites that can monitor vaccine safety for current and future vaccines.

NCT Number	NCT06833957
Lead Sponsor	Barcelona Institute for Global Health Collaborators: Fundação Manhiça, Universiteit Antwerpen, LINQ Management GMBH, Aga Khan University, University of Liverpool, Kamuzu University of Health Sciences, MU-JHU CARE, St George's, University of London, University of Oxford
Conditions	Group B Streptococcus, Invasive Bacterial Diseases (IBD), Maternal Immunization
Enrollment	18,100 participants
Start Date	2025-03-01
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-05-20