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Study identifier: NCT06833957 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Preparing for Maternal GBS Vaccine Trials in Africa

Condition: Group B Streptococcus · Invasive Bacterial Diseases (IBD) · Maternal Immunization  ·  Sponsor: Barcelona Institute for Global Health

PhaseN/A
Planned participants18100
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Azucena Bardají  ·  +34 93 2275 400  ·  azucena.bardaji@isglobal.org

Lucy Walmsley  ·  +34 93 2275 400  ·  lucy.walmsley@isglobal.org

Always discuss trial participation with your own doctor first.

Locations (10)

Mariakani Sub-County HospitalMariakani, Coast, KenyaRecruiting
Malindi Sub County Hospital in MalindiMalindi, Kilifi County, KenyaRecruiting
Rabai Sub County HospitalRabai, Kilifi County, KenyaRecruiting
Queen Elizabeth Central HospitalBlantyre, Blantyre District, MalawiRecruiting
Lirangwe Health CentreBlantyre, Blantyre District, MalawiRecruiting
Ndirande Health CentreBlantyre, Blantyre, MalawiRecruiting
Hospital Geral De MavalaneMaputo, Cidade de Maputo, MozambiqueRecruiting
Manhiça District HospitalManhiça, Manhiça, MozambiqueRecruiting
Kawempe National Referral HospitalKampala, Kampala, UgandaRecruiting
Komamboga Health Centre IIIKampala, Komamboga, UgandaRecruiting

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Source record: clinicaltrials.gov/study/NCT06833957