VAC054: Safety, immunogenicity and efficacy of FMP2.1 in AS01B
Research type
Research Study
Full title
A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium falciparum Malaria
IRAS ID
142742
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford
Eudract number
2013-004098-28
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This is a clinical trial in which healthy volunteers will be administered an experimental malaria vaccine and the efficacy of the vaccine will be tested by challenge with malaria, comparing vaccinated volunteers with a group of unvaccinated control volunteers.
The vaccine, FMP2.1, is a malaria protein and will be given with the adjuvant AS01B. Each vaccinated volunteer will get 3 vaccinations at 0, 4 and 8 weeks. The size of each group will be 15 volunteers.
The study will also assess the safety of the vaccine, and the immune response to vaccination. Immune responses are measured by tests on blood samples.
All volunteers (vaccinated and unvaccinated) will be infected with malaria by a tiny transfusion of malaria-infected red blood cells approximately 10 weeks after the first vaccination. This infection experiment will be used to assess vaccine efficacy: how well the vaccines act to slow parasite growth in the bloodstream.Healthy volunteers will be recruited in England at three research sites: in Oxford, London and Southampton.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0596
Date of REC Opinion
6 Jan 2014
REC opinion
Further Information Favourable Opinion