Safety, immunogenicity, and efficacy of blood stage vaccine candidate Rh5.1 Matrix-MTM and Rh5.2-VLP Matrix MTM in children 5-17 months in Burkina Faso

During the initial recruitment to Groups 1 and 2, participants will be randomized 1:2 to receive vaccination with the rabies control vaccination or RH5.1/Matrix-M.
During recruitment to Groups 3, 4 and 5, participants will be randomized 1:2:2 to receive vaccination with rabies control vaccination, RH5.1/Matrix-M or RH5.2-VLP/Matrix-M Efficacy of vaccination will be assessed by comparing the incidence of malaria cases in the pooled control groups (Groups 1 and 3) to the incidence of malaria in each investigational vaccine group (Groups 2,4 and 5).
There are three study vaccines: the IMP, 10μg RH5.1 adjuvanted with Matrix-M; 5μg RH5.2-VLP and Rabies Vaccine. Participants will receive the first vaccination of RH5.1 10μg with 50μg Matrix-M (Groups 2 and 4) or RH5.2 5μg with 50μg Matrix-M (Group 5). After approximately 4 weeks, a second dose will be administered, followed by a third and final vaccination approximately 4 weeks later (Groups 3-5) or approximately 4 months later (Groups 1-2). Second and third vaccinations will be administered at the same dose of both vaccine and adjuvant as at the initial vaccination and will be given within the window period of 5 months. Volunteers will be followed for 12 months from the final vaccination.

Study type: Interventional
Enrollment: 480 participants
Primary purpose: Prevention
Allocation:Randomized
Interventional Model: Parallel assignment
Masking :Double (Participant, Investigator)
NCT number: NCT05790889
Phase: Phase I/II

Clinical trial registration

Vaccines (Immune Correlates)

Apr 2023 — Aug 2024

Burkina Faso