BIO-005
Research type
Research Study
Full title
An open label phase I/IIa clinical trial to assess the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates R78C and RH5.1 in Matrix-M
IRAS ID
1010837
Contact name
Angela Minassian
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN20573724
Research summary
This is a clinical trial assessing a new malaria vaccine candidate called R78C. In this study, R78C will be used alone or in combination with another malaria vaccine called RH5.1. Both of these vaccines are protein vaccines and are modified parts of the proteins that the malaria parasite uses to enter red blood cells. We would like to find out whether these vaccines are safe and effective. In order to do this, we will recruit three groups of healthy volunteers from the Oxford area. The first group will have 13 participants who will receive three doses of the vaccine (R78C/RH5.1 with Matrix M). The second group will be participants who were previously in another trial called VAC089, where R78C (plus/minus RH5.1) was also received. This group will receive a booster dose of the same vaccine they received previously. Lastly, we will recruit a third group of ‘control’ participants. These participants will not receive any vaccinations. Up to 11 participants from each group will then be infected with malaria under controlled conditions (called a ‘malaria challenge’) and followed up closely by the study team. If our vaccine works, the diagnosis of malaria should be delayed in participants who received the vaccine, compared to those who did not.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0053
Date of REC Opinion
9 Apr 2025
REC opinion
Further Information Favourable Opinion