A Safety and Efficacy Study of R21 +/- ChAd63/MVA ME-TRAP

Summary

The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and in combination with a viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive volunteers. Healthy adult volunteers will be recruited in London, Oxford and Southampton. All vaccinations will be administered intramuscularly. The study involves having either two, three or five vaccinations and then undergoing challenge infection with malaria, or receiving no vaccinations then undergoing challenge infection with malaria.

Timeline

Start

2016-08

Primary completion

2017-12-21

Completion

2017-12-21

Publications

• Venkatraman N, Silman D, Bellamy D, Stockdale L, Bowyer G, Edwards NJ, Griffiths O, Lopez FR, Powlson J, Mair C, Folegatti PM, Datoo MS, Morter R, Minassian AM, Poulton I, Collins KA, Brod F, Angell-Manning P, Berrie E, Brendish N, Glenn G, Fries L, Baum J, Blagborough AM, Roberts R, Lawrie AM, Angus B, Lewis DJM, Faust SN, Ewer KJ, Hill AVS. R21 in Matrix-M adjuvant in UK malaria-naive adult men and non-pregnant women aged 18-45 years: an open-label, partially blinded, phase 1-2a controlled human malaria infection study. Lancet Microbe. 2025 Mar;6(3):100867. doi: 10.1016/S2666-5247(24)00083-1. Epub 2025 Jan 10.
• Ssemaganda A, Giddam AK, Zaman M, Skwarczynski M, Toth I, Stanisic DI, Good MF. Induction of Plasmodium-Specific Immune Responses Using Liposome-Based Vaccines. Front Immunol. 2019 Feb 1;10:135. doi: 10.3389/fimmu.2019.00135. eCollection 2019.

Drugs

Indications