Preparing for maternal vaccines against Group B Streptococcus in Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mariakani Sub-County Hospital
  Mariakani, Coast, Kenya Recruiting
• Malindi Sub County Hospital in Malindi
  Malindi, Kilifi County, 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

Study contacts

• Study coordinator: Azucena Bardají
• Email: azucena.bardaji@isglobal.org
• Phone: +34 93 2275 400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.