A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S. Homo sapiens

This clinical trial (NCT02252640) assesses the safety and immune responses to vaccination with experimental malaria vaccine candidates RTS,S/AS01, ChAd63 ME-TRAP and MVA ME-TRAP in different combinations. All healthy volunteers were recruited in England and administered the experimental malaria vaccines. Furthermore, volunteers were infected with malaria by mosquito bites, 12 weeks after the first vaccination to assess vaccine efficacy. Overall design: Volunteers in group G1 received vaccination with the malaria vaccine candidate, RTS,S/AS01 at a standard dose (50mg) at Week 0, 4 and 8. G2 received the same regimen, but only a fractional dose of 10mg RTS,S/AS01 at Week 8. G3 received the same regimen as G1 and in addition ChAd63 ME-TRAP at Week 0 and MVA ME-TRAP at Week 4 and 8. G4 received the same regimen as G2 and in addition ChAd63 ME-TRAP at Week 0 and MVA ME-TRAP at Week 4 and 8.