Preparing for Maternal GBS Vaccine Trials in Africa

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBarcelona Institute for Global Health

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

18,100 Participants
are grouped into 3 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