This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS \& MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP). The hope is that these vaccines will induce immune responses in vaccinees that are able to prevent malaria. This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP. The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
1 dose of ChAd63 CS 5 x 10\^10 vp intramuscularly and 1 dose MVA CS 2 x 10\^8 pfu intramuscularly 8 weeks later.
1 dose of ChAd63 ME-TRAP 5 x 10\^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10\^8 pfu intramuscularly 8 weeks later.
Approximately 3 weeks post MVA dosing
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom
Infection and Immunity Section, Imperial College of Science, Technology and Medicine
London, United Kingdom
Wellcome Trust CRF, Southampton General Hospital
Southampton, United Kingdom
The effectiveness of ChAd63-MVA CS and ChAd63-MVA ME-TRAP at preventing malaria infection
Comparison of the number of individuals who develop malaria infection between vaccinees and unvaccinated control volunteers.
Time frame: Up to 30 days post challenge
The safety and immunogenicity of ChAd63-MVA CS and ChAd63-MVA ME-TRAP
The safety of the vaccine regimens will be assessed by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements. The ability of the vaccines to induce malaria-specific immune responses (immunogenicity) will be assessed by the following laboratory tests; (A) Interferon gamma ELISPOT. (B) Flow cytometry to measure T cell responses Other laboratory investigations including microarray analysis may be performed.
Time frame: up to 7 months post first vaccination
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