R21/Matrix-M in African Children Against Clinical Malaria

Summary

Participation Requirements

Description

This will be a double-blind, individually randomised trial, with 2:1 randomisation with the R21/Matrix-M malaria vaccine or a control rabies vaccine (Abhayrab). The study groups are as follows: Standard vaccination regime, 5-36 months olds R21/Matrix-M x 3, n = 1600 Rabies vaccine x 3, n = 800 Seaso...

This will be a double-blind, individually randomised trial, with 2:1 randomisation with the R21/Matrix-M malaria vaccine or a control rabies vaccine (Abhayrab). The study groups are as follows: Standard vaccination regime, 5-36 months olds R21/Matrix-M x 3, n = 1600 Rabies vaccine x 3, n = 800 Seasonal vaccination regime, 5-36 month olds R21/Matrix-M x 3, n = 1600 Rabies vaccine x 3, n = 800 In each group, a booster (4th) dose of the same vaccine will be administered 12 months after the third dose. Initial follow-up will be for two years after dose three, with a primary analysis at 12 months after dose 3. Extension of the trial will be considered to allow for longer follow-up as indicated by the 12-month safety and efficacy data. 2400 participants will be enrolled for the standard vaccination regime in: Dande, Burkina Faso; Kilifi, Kenya; and Bagamoyo, Tanzania. In addition, a further 2400 participants will be enrolled for the seasonal vaccination regime in Nanoro, Burkina Faso and Bougouni, Mali. Study population Standard vaccination regime: 5-36 month old children living permanently in the study area who are eligible. Seasonal vaccination regime: 5-36 month old children living permanently in the study area who are eligible. Primary study objectives Efficacy: To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by Plasmodium falciparum, in 5-36 month old children living in a malaria endemic area, 12 months after completion of the primary course (standard vaccination regime). To assess the protective efficacy of R21/Matrix-M against clinical malaria caused by Plasmodium falciparum, in 5-36 month old children living in a malaria endemic area, 12 months after completion of the primary course (seasonal vaccination regime). Safety: • To assess the safety and reactogenicity of R21/Matrix-M, in both vaccination regimes, of children living in a malaria endemic area, in the month following each vaccination, and 12 months after completion of the primary course. Secondary objectives Efficacy against clinical malaria after a booster vaccination Efficacy against asymptomatic P. falciparum infection. Efficacy against severe malaria disease. Efficacy according to different transmission settings. Efficacy against incident severe anaemia, blood transfusion requirement and malaria hospitalisation. Safety and reactogenicity (including Serious adverse events (SAEs) and any deaths) following the booster vaccination and for the duration of the study. Assessment of humoral immunogenicity by anti-CSP antibody concentrations measured 12 months after completion of the primary series of 3 vaccinations and 12 months after booster vaccination

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