Phase I/IIa sporozoite challenge study of RTS,S/AS01B + ChAd63 and MVA encoding ME-TRAP and RTS,S/A01B alone (VAC055)

This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. One group of volunteers will receive a vaccination regimen composed of three doses of the RTS,S/AS01 vaccine, at 4 week intervals. Another group will receive a vaccination schedule composed of the same dosage and timing of RTS,S/AS01, but they will also receive a dose of the ChAd63 ME-TRAP vaccine at week 2, and a dose of the MVA ME-TRAP vaccine at week 8.
The vaccine schedule containing RTS,S alone, and ChAd63 ME-TRAP and MVA ME-TRAP have been tested independently in clinical trials, however, the vaccine schedule containing both RTS,S/AS01, ChAd63 ME-TRAP and MVA ME-TRAP has not yet been tested. The first principal research objective is to measure how well this new malaria vaccine strategy acts to prevent malaria disease. This is called efficacy. We will measure it by infecting volunteers with malaria and seeing whether the vaccines change how long it takes for malaria disease

Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Interventional Model: Parallel assignment
Masking :Open label
Trial Number: EUCTR2013-000393-30-GB
Phase: Phase I/IIa

ICTRP registration

Vaccines

May 2013 — Apr 2017

United Kingdom