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

Inclusion Criteria8

  • All women and their infants attending for antenatal and/or delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya.
  • 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).
  • 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 Criteria2

  • 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.

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Locations(9)

Mariakani Sub-County Hospital

Mariakani, Coast, 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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