A Safety and Efficacy Study of ChAd63/MVA METRAP + RTS,S

The goal of this phase 1/2a sporozoite challenge trial (NCT01883609) was to evaluate novel malaria vaccination regimens of the GSK pre-erythrocytic RTS,S/AS01B vaccine alone and concomitantly same-site administered with the viral vectors ChAd63 & MVA encoding the liver stage antigen construct ME-TRAP. Four vaccine groups were studied and received three vaccinations at a monthly interval. All subjects then underwent controlled human malaria infection (CHMI) 11 weeks after first vaccine administration. Volunteers in group RTSS received vaccination with the malaria vaccine candidate, RTS,S/AS01. The vaccine schedule consisted of 3 doses of RTS,S/AS01 with an interval of 4 weeks between doses (Doses given at 0,4 and 8 week timepoints). The RTSSplus group received a vaccination schedule composed of the same dosage and timing regimen of RTS,S, but they also received vaccination with ChAd63 ME-TRAP, 2 weeks after the first RTS,S followed 8 weeks later by vaccination with MVA ME-TRAP (2 and 10 week timepoints).