About this trial
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.
Eligibility criteria
Qualifiers
Infants aged less than 90 days old with laboratory-confirmed GBS infection admitted at participating health facilities in Uganda, Malawi, Mozambique, and Kenya.
Infants whose parents or guardians provided written informed consent for their participation.
Residents in the catchment area of participating health facilities.
In Uganda, Kenya and Mozambique, pregnant women at any gestation period aged 18 years and above (reproductive age).
Disqualifiers
Pregnant women who are visiting/non-resident in the research area.
Those who may be unwell and unable to consent to take part in the study.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Barcelona Institute for Global Health
Lead sponsor
Fundação Manhiça
Collaborator
Universiteit Antwerpen
Collaborator
LINQ Management GMBH
Collaborator
Aga Khan University
Collaborator
University of Liverpool
Collaborator
Kamuzu University of Health Sciences
Collaborator
MU-JHU CARE
Collaborator
St George's, University of London
Collaborator
University of Oxford
Collaborator