Preparing for Maternal GBS Vaccine Trials in Africa

Summary

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.

Conditions

• Group B Streptococcus
• Invasive Bacterial Diseases (IBD)
• Maternal Immunization

Sponsors & Collaborators

• Fundação Manhiça

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• LINQ Management GMBH

  collaborator UNKNOWN

• Aga Khan University

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Kamuzu University of Health Sciences

  collaborator OTHER

• MU-JHU CARE

  collaborator OTHER

• St George's, University of London

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Barcelona Institute for Global Health

  lead OTHER

Principal Investigators

• Eve Nakabembe · MU-JHU CARE

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2027-02-28

Completion

2027-02-28

Countries

• Kenya
• Malawi
• Mozambique
• Uganda

Study Locations