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.

Principal Institution

University of Oxford, United Kingdom

Principal Investigators / Focal Persons

Umberto D’Alessandro

Partner Institutions

European and Developing Countries Clinical Trials Partnership (EDCTP), The Netherlands
Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, The Gambia

Rationale and Abstract

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 Design

Study type: Interventional

Enrollment: 96 participants

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Masking: None (Open Label)

Primary purpose: Prevention

External reference

Clinical trial registration

Thematic Categories

Product Development
Vaccines (Immune Correlates)