A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

Summary

Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.

Timeline

Start

2012-11

Primary completion

2014-08

Completion

2014-09

Publications

• Morter R, Tiono AB, Nebie I, Hague O, Ouedraogo A, Diarra A, Viebig NK, Hill AVS, Ewer KJ, Sirima SB. Impact of exposure to malaria and nutritional status on responses to the experimental malaria vaccine ChAd63 MVA ME-TRAP in 5-17 month-old children in Burkina Faso. Front Immunol. 2022 Dec 2;13:1058227. doi: 10.3389/fimmu.2022.1058227. eCollection 2022.
• Tiono AB, Nebie I, Anagnostou N, Coulibaly AS, Bowyer G, Lam E, Bougouma EC, Ouedraogo A, Yaro JBB, Barry A, Roberts R, Rampling T, Bliss C, Hodgson S, Lawrie A, Ouedraogo A, Imoukhuede EB, Ewer KJ, Viebig NK, Diarra A, Leroy O, Bejon P, Hill AVS, Sirima SB. First field efficacy trial of the ChAd63 MVA ME-TRAP vectored malaria vaccine candidate in 5-17 months old infants and children. PLoS One. 2018 Dec 12;13(12):e0208328. doi: 10.1371/journal.pone.0208328. eCollection 2018.

Drugs

Indications