A Phase I Study to Assess Malaria Vaccine R21 with AS01B
Research type
Research Study
Full title
A Phase I study to assess the safety and immunogenicity of a protein particle malaria vaccine candidate, R21, administered with AS01B in healthy UK volunteers.
IRAS ID
186162
Contact name
Adrian Hill
Contact email
Eudract number
2015-002949-57
Clinicaltrials.gov Identifier
15/LO/1353,
Duration of Study in the UK
0 years, 9 months, 24 days
Research summary
This is an open label Phase I study of a protein particle malaria vaccine candidate in healthy volunteers. R21 will be administered intramuscularly with the adjuvant AS01B.
There will be two study groups, each containing 10 volunteers.
Group one will receive a lower dose R21 vaccine (10ug) with the adjuvant AS01B at three timepoints; day 0, 28 and 56.
Group two will receive a higher dose R21 vaccine (50ug) with adjuvant AS01B at three timepoints; day 0, 28 and 56.
The study will assess the safety of the vaccinations, and the immune responses to these vaccinations. Immune responses are measured by tests on blood samples.
The R21 vaccine contains a protein which is found on the malaria parasite (plasmodium falciparum) so that the immune system builds a response to malaria. AS01B is a vaccine adjuvant which is added to the vaccine to produce a stronger immune response.
Healthy volunteers will be recruited in Oxford and Southampton, England. The study will be funded by an EU grant.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1353
Date of REC Opinion
3 Sep 2015
REC opinion
Favourable Opinion