Co-administration of RTS,S and viral vectors expressing ME-TRAP
Research type
Research Study
Full title
A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of Concomitant Administration of the Combination Malaria Vaccine Candidate Regimen of RTS,S/AS01¬B + ChAd63 and MVA encoding ME-TRAP and also RTS,S/AS01B alone
IRAS ID
155133
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford
Eudract number
2014-001301-40
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
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 leading malaria vaccine candidate, RTS,S/AS01. One group will receive 3 standard doses of RTS,S/AS01, while another will receive 2 standard doses of RTS,S/AS01 with a fractional 3rd dose (consisting of one fifth of the standard dose). Two other groups will receive vaccination with RTS,S, but they will also receive concurrent vaccination with ChAd63 ME-TRAP with the first RTS,S and MVA ME-TRAP with the next two doses of RTS,S. One of these two groups will receive 3 standard doses of RTS,S, the other will receive a fractional 3rd dose. Vaccines will be delivered at 4 week intervals (ie. At 0, 4 & 8 weeks).
The 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, 11 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.
The RTS,S/AS01 vaccine is a protein (RTS,S) mixed with an adjuvant (AS01). 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.
Healthy volunteers will be recruited in England at four research sites: in Oxford, London, Guildford and Southampton.REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0227
Date of REC Opinion
12 May 2014
REC opinion
Favourable Opinion