Malaria, Falciparum Clinical Trial
Official title:
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M, Both Alone and in Combination, in Healthy UK Adults
This is an open-label, single-centre Phase I P. falciparum blood-stage vaccine trial to assess the safety and immunogenicity and efficacy of the candidate malaria vaccines R78C and RH5.1 formulated in adjuvant Matrix-M
Volunteers will be recruited into one of four groups (n=8+1 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. Volunteers in groups 1, 2 and 4 will be followed up for a total of approximately 12 months. There will be 3 sentinel participants in each group (and for each successive vaccination), which will require an independent safety review prior to each successive vaccination. Group 3 is not a first-in-human group and so can be recruited at any time and participants will be followed up for a total of approximately 20 months from first vaccination. All volunteers will be given 10 µg R78C and/or 10 µg RH5.1 soluble protein in combination with 50 µg of Matrix-M via intramuscular (IM) injection in the deltoid region of the non-dominant arm. ;
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