Safety, immunogenicity and efficacy of RH5.1/AS01 (VAC063)
Research type
Research Study
Full title
A Phase I/IIa clinical trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium falciparum malaria vaccine candidate RH5.1/AS01
IRAS ID
206835
Contact name
Angela Minassian
Contact email
Sponsor organisation
University of Oxford, CTRG
Eudract number
2016-001718-31
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Malaria is a major global problem, with 3.2 billion people living at risk of malaria infection. There is a need for a safe, effective malaria vaccine as the range of effective medicines for treating malaria is limited and resistance to commonly used medicines is increasing. Currently there is no approved malaria vaccine available. The purpose of this study is to assess a new malaria vaccine, RH5.1/AS01 at different doses and with different dosing schedules. The first part of the study (groups 1 – 4) will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving participants three doses of the RH5.1/AS01 vaccine, doing blood tests and collecting information about any symptoms that occur after vaccination. Using some of the information from Groups 1, 2 & 4 to assess the best dose, we will then test how effective the vaccine is at preventing malaria in vaccinated individuals (Group 5) compared with participants who have not received a vaccine (Group 6).The study will take place at hospital sites in Oxford, London and Southampton. In order to participate in the study volunteers must: be a healthy adult aged between 18 and 45 years; be able and willing (in the Investigator’s opinion) to comply with all study requirements; allow the Investigators to discuss their medical history with their GP; practice continuous effective contraception for the duration of the study (women only); refrain from blood donation. Volunteers who take part in this study, will be involved in the trial for approximately 8 months if they are in groups 1, 2, 4, or 5 and 1 year if they are enrolled into group 3. Group 6 participants will be enrolled for approximately 3 months.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0345
Date of REC Opinion
18 Aug 2016
REC opinion
Further Information Favourable Opinion