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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* WP2 Pregnancy Exposure Registries inclusion criteria:
All women and their infants attending for antenatal and/or delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya.
WP3 GBS Surveillance inclusion criteria:
* 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.
WP4 Vaccine Confidence inclusion criteria:
* In Uganda, Kenya and Mozambique, pregnant women at any gestation period aged 18 years and above (reproductive age).
* In Malawi, pregnant women aged 16 years are eligible to be included in the study because they are considered emancipated minors.
* Pregnant women who consent to the study and give written consent.
* Stakeholders who include pregnant women, health workers, women leaders, community leaders, national stakeholders, cultural and religious leaders who are willing to take part and can give written informed consent.
Exclusion Criteria:
WP4 Vaccine Confidence exclusion criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pregnancy exposure registries outcome 1.1
Timeframe: 01.03.2026 - 28.02.2027
2
Pregnancy exposure registries outcome 1.2
Timeframe: 01.03.2026 - 28.02.2027
3
Pregnancy exposure registries outcomes 1.3
Timeframe: 01.03.2026 - 28.02.2027
4
Sentinel site GBS disease surveillance outcome 2.1
Timeframe: 01.01.2025 - 01.09.2025
5
Sentinel site GBS disease surveillance outcome 2.2