RecruitingNCT06833957

Preparing for Maternal GBS Vaccine Trials in Africa

PReparing for OptimalPhase III/IV maTErnal Group B StreptococCal Vaccine Trials in Africa (PROTECT)


Sponsor

Barcelona Institute for Global Health

Enrollment

18,100 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with group b streptococcus, invasive bacterial diseases (ibd), and other related conditions. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(10)

Mariakani Sub-County Hospital

Mariakani, Coast, Kenya

Malindi Sub County Hospital in Malindi

Malindi, Kilifi County, Kenya

Rabai Sub County Hospital

Rabai, Kilifi County, Kenya

Queen Elizabeth Central Hospital

Blantyre, Blantyre District, Malawi

Lirangwe Health Centre

Blantyre, Blantyre District, Malawi

Ndirande Health Centre

Blantyre, Blantyre, Malawi

Hospital Geral De Mavalane

Maputo, Cidade de Maputo, Mozambique

Manhiça District Hospital

Manhiça, Manhiça, Mozambique

Kawempe National Referral Hospital

Kampala, Kampala, Uganda

Komamboga Health Centre III

Kampala, Komamboga, Uganda

View Full Details on ClinicalTrials.gov

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NCT06833957


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