This is a Phase Ib, open-label, non-randomised, controlled trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in 5-36 month old African children living with HIV.~The study will be conducted in Uganda at the MRC/UVRI and LSHTM Uganda research unit with recruitment taking place in Kampala, Wakiso and Entebbe.~Children aged 5-36 months will be recruited to the trial. 100 children with confirmed HIV infection will be recruited to group 1. 20 children without HIV infection will be recruited to group 2. Up to 10% variation for each group will be permitted to accommodate variation in the rate of recruitment and retention.~HIV positive children will be recruited from Paediatric HIV care centres within Kampala and Wakiso districts. HIV negative children will be recruited from Entebbe hospital and primary health care centres that provide immunisation and growth monitoring services.~All participants will receive 3 vaccinations of 5µg R21/50µg Matrix-M™. Participants will receive their first dose at 0 months, second dose at 1 month and third dose at 2 months. Participants will receive a booster at 14 months (12 months after their third dose). Participants will be followed up for 12 months following the primary vaccination series and one month following the booster dose.~Primary objective:~To assess the safety and reactogenicity profile of the malaria vaccine candidate R21/Matrix-M™ in 5-36-month old African children living with HIV~Secondary objectives:~To assess the humoral immunogenicity of R21/Matrix-M™ in 5-36-month-old African children, comparing children living with HIV with HIV negative children~To assess the impact of vaccination on HIV reservoir~To assess whether increasing age and nadir CD4 count are associated with immunogenicity of R21/Matrix-M™ in 5-36-month-old African children living with HIV~Tertiary objective:~To assess the immunogenicity profile of R21/Matrix-M™ in 5-36-month-old African children, comparing children living with HIV with HIV negative children~This trial is funded by the Serum Institute of India Pvt Ltd.
A Phase Ib trial to evaluate the safety and immunogenicity of R21/Matrix-M™ in African children living with HIV