Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study

Summary

A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether administration of further doses of the malaria vaccine RTS,S/AS01 at the beginning of the malaria transmission until children reach the age of five years is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful protection when given together with SMC. The primary trial end-point will be the incidence of clinical episodes of malaria detected by passive case detection. This is a two year extension of the current RTS,S/AS01 + SMC trial to continue the trial until the study children reach the age of five years, the current age at which SMC is recommended until.

Timeline

Start

2020-04-01

Primary completion

2022-03-31

Completion

2022-03-31

Publications

• Dicko A, Ouedraogo JB, Zongo I, Sagara I, Cairns M, Yerbanga RS, Issiaka D, Zoungrana C, Sidibe Y, Tapily A, Nikiema F, Sompougdou F, Sanogo K, Kaya M, Yalcouye H, Dicko OM, Diarra M, Diarra K, Thera I, Haro A, Sienou AA, Traore S, Mahamar A, Dolo A, Kuepfer I, Snell P, Grant J, Webster J, Milligan P, Lee C, Ockenhouse C, Ofori-Anyinam O, Tinto H, Djimde A, Chandramohan D, Greenwood B. Seasonal vaccination with RTS,S/AS01E vaccine with or without seasonal malaria chemoprevention in children up to the age of 5 years in Burkina Faso and Mali: a double-blind, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2024 Jan;24(1):75-86. doi: 10.1016/S1473-3099(23)00368-7. Epub 2023 Aug 22.

Drugs

Indications