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Last Updated: 27/10/2022
A Phase Ib multi-stage Plasmodium Falciparum malaria vaccine study to assess the experimental malaria vaccines RH5.2-VLP and R21.
Objectives
To assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia.
A total of 96 volunteers will be enrolled. Adults (18-45 years) will be enrolled into groups 3 -5. Infants (5 -17 months) will be enrolled into groups 1-2 and groups 6-9. All volunteers will be given 3 doses 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 via intramuscular (IM) injection in the deltoid region of the non-dominant arm for adults and anterolateral thigh for infants. The first 2 doses will be given at months 0 and 1. Groups 2-6 and group 8 will be given the third dose at month 2, and groups 1, 7 and 9 will be given the third dose at month 6.
NCT number: NCT05357560
Study type: Interventional
Enrollment: 96 participants
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Feb 2023 — Jul 2025
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