A Phase I Study to Assess Malaria Vaccine R21 with Matrix-M1
Research type
Research Study
Full title
Safety and immunogenicity of a protein particle malaria vaccine candidate, R21, administered with and without Matrix-M1 in healthy UK volunteers
IRAS ID
184023
Contact name
Adrian Hill
Contact email
Eudract number
2015-002428-19
Duration of Study in the UK
0 years, 10 months, 15 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 alone or with the adjuvant Matrix-M1.
There will be 3 study groups, with Groups 1 and 3 containing 10 volunteers and Group 2 containing 4 volunteers.
Group one will receive a lower dose R21 vaccine (10ug) with the adjuvant Matrix-M1 at three timepoints; day 0, 28 and 56.
Group two will receive a higher dose R21 vaccine (50ug) with no adjuvant at three timepoints; day 0, 28 and 56.
Group three will receive the higher dose R21 vaccine (50ug) with the adjuvant Matrix-M1 at three timepoints; day 0, 28 and 56.
The study will assess the safety of the vaccinations with and without the adjuvant (Matrix-M1), 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. Matrix-M1 is a vaccine adjuvant which is added to the vaccine to produce a stronger immune response.
Healthy volunteers will be recruited in Oxford and London, England. The study will be funded by an EU grant.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0386
Date of REC Opinion
24 Jul 2015
REC opinion
Further Information Favourable Opinion