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PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT)

Project description

Maternal vaccine safety and delivery in developing countries

Two vaccines are in late-phase development to protect unborn infants from group B Streptococcus and respiratory syncytial virus. Before approval, they must demonstrate effectiveness and safety. However, healthcare systems in developing countries require improvements, including enhanced vaccine safety monitoring and surveillance, better vaccine delivery and increased patient participation. Electronic health records (EHRs) in Kenya, Malawi, Mozambique and Uganda are essential. The EU-funded PROTECT project aims to address gaps in EHR systems by developing pregnancy registries embedded within national reporting systems. These registries will enable the monitoring of potential safety signals for maternal vaccines. The project will conclude with the establishment of a network of maternal vaccine trial sites to expedite the evaluation of vaccines during pregnancy.

Objective

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.

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Topic(s)

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HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2023-01

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Coordinator

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 618 057,50
Address
C ROSSELLO 132 PLANTA 05
08036 Barcelona
Spain

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Region
Este Cataluña Barcelona
Activity type
Research Organisations
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 618 057,50

Participants (6)

Partners (3)

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