Preparing for maternal vaccines against Group B Streptococcus in Africa
PReparing for OptimalPhase III/IV maTErnal Group B StreptococCal Vaccine Trials in Africa (PROTECT)
This study is trying to set up better ways to track pregnancy and baby health in East Africa to prepare for future vaccines against Group B Streptococcus, which can be dangerous for newborns.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 18100 (estimated) |
| Sex | All |
| Sponsor | Barcelona Institute for Global Health Academic / other |
| Locations | 9 sites (Mariakani, Coast and 8 other locations) |
| Trial ID | NCT06833957 on ClinicalTrials.gov |
What this trial studies
This project aims to establish uniform data collection processes for pregnancy and infant health in East Africa, focusing on Group B Streptococcus (GBS) infections, which are a leading cause of newborn deaths. It involves creating pregnancy exposure registries and developing microbiological surveillance for GBS in newborns. The initiative will enhance vaccine safety monitoring and improve healthcare systems to support future vaccine trials. By strengthening reporting systems, the project prepares medical sites for the implementation of GBS vaccines once they are developed.
Who should consider this trial
Good fit: Ideal candidates include pregnant women attending antenatal services and their infants under 90 days old at participating health facilities in Uganda, Malawi, Mozambique, and Kenya.
Not a fit: Patients who are not pregnant or whose infants are older than 90 days may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly reduce newborn deaths caused by GBS infections through effective maternal vaccination.
How similar studies have performed: Other studies have shown promise in maternal vaccination approaches, particularly in reducing neonatal infections, making this initiative a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mariakani, Coast and 8 other locations
- Mariakani Sub-County Hospital — Mariakani, Coast, Kenya (Recruiting)
- Rabai Sub County Hospital — Rabai, Kilifi County, Kenya (Recruiting)
- Queen Elizabeth Central Hospital — Blantyre, Blantyre District, Malawi (Recruiting)
- Lirangwe Health Centre — Blantyre, Blantyre District, Malawi (Recruiting)
- Ndirande Health Centre — Blantyre, Blantyre, Malawi (Recruiting)
- Hospital Geral De Mavalane — Maputo, Cidade de Maputo, Mozambique (Recruiting)
- Manhiça District Hospital — Manhiça, Manhiça, Mozambique (Recruiting)
- Kawempe National Referral Hospital — Kampala, Kampala, Uganda (Recruiting)
- Komamboga Health Centre III — Kampala, Komamboga, Uganda (Recruiting)
Study contacts
- Study coordinator: Azucena Bardají
- Email: azucena.bardaji@isglobal.org
- Phone: +34 93 2275 400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.