A Study to Assess New Malaria Vaccines ChAd63 RH5 and MVA RH5 (VAC057)
Research type
Research Study
Full title
A Phase Ia clinical trial to assess the safety and immunogenicity of new Plasmodium falciparum malaria vaccine candidates ChAd63 RH5 alone and with MVA RH5
IRAS ID
148967
Contact name
Heather House
Contact email
Sponsor organisation
University of Oxford
Eudract number
2013-005458-31
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This study aims to assess the safety and immunogenicity of two novel Plasmodium falciparum malaria vaccines: ChAd63 RH5 and MVA RH5. The vaccines consist of viruses which have been modified so they can’t replicate in humans and include genetic material from the malaria parasite (RH5). This is a protein involved in malaria invasion of red blood cells. The vaccines are designed to stimulate an immune response to this malaria protein (immunogenicity describes the nature and magnitude of this immune response) to provide protection against malaria by preventing the parasites from entering red blood cells.
This vaccine has not been used in humans before, but the viruses (ChAd63 and MVA) have been used in multiple vaccine studies in Oxford with Plasmodium falciparum malaria proteins and have been safe and immunogenic. Pre-clinical studies have also demonstrated that the vaccine is safe and immunogenic.
Two doses of each vaccine will be used in this study. A lower dose of each vaccine will be given first, and only if safe will a higher dose be given.
24 volunteer will be recruited in total. 4 volunteers will receive a low dose of the ChAd63 RH5 vaccine initially, and if this is safe the dose will be escalated. A further 4 volunteers will receive a higher dose of ChAd63 RH5. If this dose is safe 8 more volunteers will receive the same (higher) dose, followed eight weeks later by a low dose of the MVA RH5 vaccine. If this regimen with the 2 vaccines is safe we will go on to vaccinate a further 8 volunteers. These 8 will receive the higher dose of ChAd63 RH5 and a higher dose of MVA RH5 eight weeks later.
The study will be conducted at the CCVTM, Oxford and at the NIHR WTCRF, Southampton. It is funded by European Commission funding.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0120
Date of REC Opinion
12 Mar 2014
REC opinion
Favourable Opinion