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PROTECT

Preparing for Optimal Phase III/IV maternal Group B Streptococcal vaccine Trials in Africa

Funder

Global Health EDCTP3 Joint Undertaking, supported by the European Union

Type of Study

Observational & qualitative (depending on the workpackage)

Sponsor

ISGlobal

Country

Kenya, Malawi, Mozambique & Uganda

Chief Investigator

Dr Azucena Bardají (Co-chief Investigator: Prof Kirsty Le Doare)

Participants

Infants under 90 days old; pregnant women; community members; policy makers; major stakeholders

Summary

Two vaccines designed for pregnant women, to protect their unborn infant, are entering late phase development and will prevent infections from group B Streptococcus and respiratory syncytial virus, respectively. For these vaccines to be approved, the vaccine must work effectively without causing any unwanted responses. To implement these vaccines in countries with low resources, healthcare systems must be strengthened by improving vaccine safety monitoring and surveillance of infection, and advancing vaccine delivery, vaccine confidence, and patient participation.

The rapid rollout of electronic health records (EHR) in Kenya, Mozambique, Malawi, and Uganda offers an opportunity to use routine data to strengthen reporting of rates of adverse pregnancy, neonatal and infant outcomes, and any adverse events following immunisation; this will be imperative in informing and preparing for future large scale vaccination rollout campaigns. Our approach will address key gaps in EHR to develop pregnancy registries embedded within national reporting systems to establish this data, including baseline rates of pregnancy and infancy outcomes for Tetanus and COVID19 vaccines currently in use. These reporting systems will allow monitoring of potential safety signals once new vaccines are introduced. Experts in EHR, obstetrics and gynaecology, paediatrics, microbiology, clinical trials, and implementation research will develop the motivation and tools needed to monitor and evaluate current and future maternal vaccines.

We will work closely with the WHO, African Medicines Agency and Country Stakeholders, co-developing pregnancy registries, sentinel site microbiological surveillance systems, and maternal vaccination communications toolkits in preparation for the decade of maternal vaccines. Our programme of work culminates in a network of maternal vaccine trial sites who can rapidly evaluate vaccines in pregnancy from late-stage trials through to introduction on a national level.

Duration

March 2024 – February 2027

Collaborators