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VAC 76

·Project:

A Phase Ib/IIb randomised controlled trial of the safety, immunogenicity and efficacy of a candidate malaria vaccine, R21 adjuvanted with Matrix-M (R21/MM), in 5-17 month old children in Nanoro, Burkina Faso

 

   
·Identity of the Study Site PIs and Coordinator

PI: Prof. Halidou TINTO

Co-Pi: Dr Hermann SORGHO

Coordinator: Dr H. Magloire Natama

   
·Summary : Malaria control and elimination remain a challenge without an effective vaccine. The recent leading malaria vaccine candidate, RTS,S, has shown to induce partial efficacy so that there is an urgent need for a highly effective, deployable, and affordable second generation of malaria vaccine. R21 which is a novel pre-erythrocytic candidate malaria vaccine is a biosimilar protein particle to RTS,S vaccine. Indeed, R21 comprises only fusion protein moieties (i.e. 100% of its particles), in contrast to RTS,S which comprises 20% of these with the remaining 80% being HBsAg. R21 has demonstrated to be safe, non-toxic and immunogenic with a range of adjuvants including Matrix-M, a novel adjuvant designed to stimulate both humoral and cellular immune responses to vaccines in both pre-clinical and clinical studies. In VAC076 trial, we are assessing in a phase Ib/IIb trial, the safety, the immunogenicity and the efficacy of R21 adjuvanted with Matrix-M (R21/MM) in 5-17 months old children in Nanoro (Burkina Faso). These children were randomized (1:1:1) to receive three doses, 4 weeks apart, of either 5µg R21/25µg MM (Group 1), 5µg R21/50µg MM (Group 2) or rabies vaccine (Group 3, control group). Follow-up is for 24 months, with administration of a booster dose approximately 12 months after the third dose, prior to the start of the malaria season.
   
· Field of application: Vaccine clinical trial
   
· Objectives:

Primary objective

To assess the protective efficacy against clinical malaria of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria- endemic area, for 6 months after the third vaccination.

Secondary objective:

Duration of Protective efficacy against clinical malaria

To assess the protective efficacy against clinical malaria of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria- endemic area, for 12 months after administration of the third dose of vaccine.

To assess the protective efficacy against clinical malaria of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria- endemic area, for 6 months after a booster vaccination.

To assess the protective efficacy against clinical malaria of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria- endemic area, for 12 months after a booster vaccination.

Efficacy against asymptomatic P. falciparum infectionTo assess the protective efficacy against asymptomatic P. falciparum infection of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria-endemic area, at 12 months after administration of the third dose of vaccine.

To assess the protective efficacy against asymptomatic P. falciparum infection of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria-endemic area, at 12 months after administration of the booster dose of vaccine.

Safety Objectives

To assess the safety and reactogenicity of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria-endemic area, in the month following each vaccination and at 12 months after administration of the third dose of vaccine.

To assess the safety and reactogenicity of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria-endemic area, in the month following each vaccination and at 12 months after administration of the booster dose of vaccine.

Immunogenicity Objectives

To assess the humoral immunogenicity of R21 adjuvanted with Matrix-M in 5-17 months old children living in a malaria-endemic area.

   
·Start Date: 06 May 2019
   
· Probable End Date: 02 July 2021

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