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.

Conditions

• Malaria,Falciparum
• Child, Only

Interventions

BIOLOGICAL

Tetanus/diphtheria toxoids

One dose of tetanus/diphtheria toxoids vaccine (June) in year 1 and year 2.

DRUG

SMC with SP+AQ

Year 1 and 2 (2020/21) Four cycles of SMC (SP+AQ) (July, August, September, October). One cycle of SMC consisting of sulphadoxine - pyrimethamine (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3.

BIOLOGICAL

RTS,S/AS01

One booster dose of RTSS/AS01 (June) in year 1 and 2.

DRUG

SMC placebo

Year 1 and 2 (2020/21) Four cycles of SMC placebo (July, August, September, October)

Sponsors & Collaborators

• Malaria Research and Training Center, Bamako, Mali

  collaborator OTHER

• Institut de Recherche en Sciences de la Sante, Burkina Faso

  collaborator OTHER_GOV

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Alassane Dicko, Professor · Malaria Research & Training Center, Bamako

• Jean Bosco Ouedraogo, Professor · Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS-DRO)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-01

Primary Completion

2022-03-31

Completion

2022-03-31

Countries

• Burkina Faso
• Mali

Study Locations