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

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.