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R21/M-Malaria vaccine to extend the protection of Post-Discharge Malaria Chemoprevention in children recovering from severe anaemia: a randomised-controlled trial in Malawi, Kenya and Uganda

Project description

Assessing R21/M-Malaria vaccine's extended protection in African children

Post-discharge malaria chemoprevention is a strategy to reduce death and re-hospitalisation in children recovering from severe anaemia. However, it only protects for up to four months after discharge, even though the risk of mortality and morbidity lasts for up to one year. The EU-funded R21-PD project aims to provide scientific evidence for the World Health Organization (WHO) on the long-term efficacy, safety, acceptability and cost-effectiveness of the R21/Matrix-Malaria vaccine. It aims to extend malaria prevention from four months to 12 months for children in malaria-endemic regions of sub-Saharan Africa. The project will conduct a randomised controlled clinical trial in Kenya, Malawi and Uganda, along with sub-studies, to assess immunogenicity, acceptability and cost-effectiveness.

Objective

The overall goal of this project is to provide scientific evidence for WHO policymaking on the longterm efficacy, safety, acceptability and cost-effectiveness of using R21/Matrix-Malaria vaccine to extend the duration of malaria chemoprevention from 4 to 12 months in children recovering from severe anaemia in highly malaria-endemic areas in sub-Saharan Africa. This project will generate long-term safety and efficacy data and also generate pharmacovigilance data on a currently registered vaccines of R21/M-malaria vaccine in a under-studied patient population group.

Post-discharge Malaria Chemoprevention, a malaria control strategy recently recommended by WHO to reduce the risk of death or re-hospitalization in children recovering from severe anaemia. However this strategy only provides this protection during the first 3-4 months post-discharge, although their risk of mortality and morbidity extends over 12 months. This project will determine whether providing R21 malaria vaccine will provide this extended malaria protection.

We shall conduct a randomised-controlled clinical trial in Malawi, Kenya and Uganda to determine whether providing a booster dose of R21 malaria vaccine will reduce death and re-hospitalizations over a 12-month follow-up period compared to providing PDMC over 3 months with a monthly treatment course of an antimalarial (DP) in children recovering from severe anaemia. We shall also conduct sub-studies in order to determine the immunogenicity, acceptability from the patient and providers’ perspective and the cost-effectiveness including a budget impact analysis of this intervention. Lastly, we shall engage local and international policymakers to facilitate uptake of our findings and possible policy adoption.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

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

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Call for proposal

(opens in new window) HORIZON-JU-GH-EDCTP3-2024-01-two-stage

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Coordinator

LIVERPOOL SCHOOL OF TROPICAL MEDICINE
Net EU contribution
€ 922 043,74
Address
PEMBROKE PLACE
L3 5QA LIVERPOOL 3
United Kingdom
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 1 194 407,47

Participants (6)