A Study to Assess Malaria Vaccines ChAd63/MVA Pfs25-IMX313
Research type
Research Study
Full title
A Phase Ia clinical trial to assess the safety, immunogenicity and ex-vivo efficacy of new Plasmodium falciparum malaria vaccine candidates ChAd63 Pfs25-IMX313 alone and with MVA Pfs25-IMX313
IRAS ID
179459
Contact name
Adrian Hill
Contact email
Sponsor organisation
Research & Development Department - Oxford University Hospitals NHS Foundation Trust
Eudract number
2015-000637-73
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
This study aims to assess the safety and immunogenicity of two novel malaria transmission blocking vaccines: ChAd63 Pfs-IMX313 and MVA Pfs25-IMX313. The vaccines consist of viruses which have been modified so they can't replicate in humans and include genetic material from the malaria parasite (encoding the protein Pfs25) fused to a carrier protein (IMX313) which increases the immune response to the parasite protein. Pfs25 is a protein expressed by the malaria parasite whilst it is inside the mosquito. The concept of transmission-blocking vaccines is to vaccinate against the sexual stages of the malaria parasite and prevent onwards transmission of infection via the mosquito. Infection is not primarily prevented in the human host, but future infections can be prevented- it has therefore been termed an ‘altruistic’ vaccine strategy by some.
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.
Two doses of each vaccine will be used in this study. A lower dose of each vaccine will be given first in a small group of volunteers, and only if safe will a higher dose be given to the remaining volunteers.
24 volunteers will be recruited in total.
The study will be conducted at the NIHR WTCRF, Southampton and at the CCVTM, Oxford. It is funded by European Commission funding.REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0237
Date of REC Opinion
8 May 2015
REC opinion
Favourable Opinion