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
This trial accepts healthy volunteersQualifiers
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 population
WP2 Pregnancy Exposure Registries study population: Pregnant women and their infants up to hospital discharge at the chosen health facilities in Uganda, Malawi, Mozambique, and Kenya. WP3 GBS surveillance study population: All infants less than 90 days old admitted with GBS infection detected in blood or CSF by culture, or GBS detected in CSF by qPCR, at referral health facilities in the four countries during a period of at least 12 months. WP4 study population: All pregnant women attending the identified health facilities at the time of fieldwork and the health care workers who provide services to these women. It will also consist of stakeholders including, but not limited to, health workers from each country's Ministry of Health, head of facilities, community leaders (community gatekeepers and influencers), older women who give support in the community, male leaders, religious, political, administrative or cultural leaders.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
18,100 Participants
are grouped into 3 trial groupsGroup A: WP2: Pregnancy Episode Registries
Group B: WP3: GBS disease sentinel site surveillance
Group C: WP4: Vaccine confidence
Trial outcomes
Primary outcomes
1
Pregnancy exposure registries outcome 1.1
To establish pregnancy episode registries at sentinel site locations, at least 1 site per country.
Time frame
01.03.2026 - 28.02.20272
Pregnancy exposure registries outcome 1.2
To generate longitudinal cohort data on pregnancies, deliveries and infant outcomes for maternal vaccine safety assessment, specifically rates of obstetric and neonatal outcomes as defined by the GAIA project.
Time frame
01.03.2026 - 28.02.20273
Pregnancy exposure registries outcomes 1.3
To generate comparable essential data across Kenya, Malawi, Mozambique and Uganda on adverse pregnancy, neonatal and infant outcomes using consensus definitions for maternal vaccine safety assessment.
Time frame
01.03.2026 - 28.02.20274
Sentinel site GBS disease surveillance outcome 2.1
To develop and strengthen capacities for GBS disease surveillance in infants less than 90 days old at sentinel sites in four African countries, using microbiological and molecular detection methods.
Time frame
01.01.2025 - 01.09.2025Secondary outcomes
1
Sentinel site GBS disease surveillance outcome 2.3
To assess the antimicrobial resistance patterns of GBS isolates among infants less than 90 days old.
Time frame
01.09.2025 - 28.02.20272
Sentinel site GBS disease surveillance outcome 2.4
To determine the genomic profile of iGBS strains.
Time frame
01.09.2025 - 28.02.2027Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov