Last Updated: 03/05/2024

ChAd63 ME-TRAP and MVA ME-TRAP delivered with RTS,S/AS01B (at full standard or fractional 3rd dose), and of RTS,S/AS01B alone (at full standard or fractional 3rd dose) (VAC059)

Objectives

The objectives of this study are:
1. to assess the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of a combination immunization regimen of ChAd63 ME-TRAP and MVA ME-TRAP delivered concomitantly with RTS,S/AS01B, at either full standard dose or with a fractional 3rd dose (1/5 standard dose) and of RTS,S/AS01B alone with a fractional 3rd dose, against malaria sporozoite challenge, in healthy malaria-naïve volunteers.
2. to assess the safety of a combination immunization regimen of ChAd63 ME-TRAP and MVA ME-TRAP delivered concomitantly with RTS,S/AS01B, at either full standard dose or with a fractional 3rd dose (1/5 standard dose) and of RTS,S/AS01B alone at either full standard dose or with a fractional 3rd dose, in healthy malaria-naïve volunteers.

Principal Investigators / Focal Persons

Adrian VS Hill

Rationale and Abstract

This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. Two groups of volunteers will receive vaccination with the leading malaria vaccine candidate, RTS,S/AS01. One group will receive 3 standard doses of RTS,S/AS01, while another will receive 2 standard doses of RTS,S/AS01 with a fractional 3rd dose (consisting of one fifth of the standard dose). Two other groups will receive vaccination with RTS,S, but they will also receive concurrent vaccination with ChAd63 ME-TRAP with the first RTS,S and MVA ME-TRAP with the next two doses of RTS,S. One of these two groups will receive 3 standard doses of RTS,S, the other will receive a fractional 3rd dose. Vaccines will be delivered at 4 week intervals (ie. At 0, 4 & 8 weeks).
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.

Study Design

Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Masking :Open label
Trial Number: EUCTR2014-001301-40-GB
Phase: Phase I/IIa

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