A Safety and Efficacy Study of R21 + ChAd63/MVA ME-TRAP (VAC065)
Research type
Research Study
Full title
A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of adjuvanted R21 at two different doses and the Combination Malaria Vaccine Candidate Regimen of adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP.
IRAS ID
204512
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford, CTRG
Eudract number
2016-001265-92
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 2 days
Research summary
This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. Two groups of volunteers will receive vaccination with the novel malaria vaccine candidate, R21 at two different doses given in combination with the vaccine adjuvant, Matrix M1. Vaccines will be delivered at 4 week intervals (ie. At 0, 4 & 8 weeks). A third group will receive low dose R21 with Matrix M1 at 0, 4 and 8 weeks in combination with ChAd63 ME-TRAP and MVA ME-TRAP given at 1 and 9 weeks, respectively. \nThe study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples. Volunteers will be infected with malaria by mosquito bites, 12 weeks after the first vaccination. In addition, a group of volunteers not receiving vaccines will also be infected with malaria by the same method. These infection experiments will be used to assess vaccine efficacy: how well the vaccines act to prevent malaria disease.\nR21 is a protein particle, which is produced by combining a protein from Hepatitis B with the circumsporozoite protein (CSP) of the malaria parasite. This is not a live vaccine and so there is no chance of catching malaria. The ChAd63 ME-TRAP and MVA ME-TRAP vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes malaria proteins (but malaria does not develop), so that the immune system builds a response to malaria without having been infected by it.\nHealthy volunteers will be recruited in England at three research sites: in Oxford, London, and Southampton.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0261
Date of REC Opinion
25 May 2016
REC opinion
Favourable Opinion