Protocol No: ECCT/12/12/01 Date of Protocol: 17-11-2012

Study Title:

 

A pilot study to optimise controlled human malaria infections in humans with varying degrees of prior exposure to malaria using P. falciparum sporozoites administered by needle and syringe

Study Objectives:
Laymans Summary:
Abstract of Study:

 

Controlled human malaria infection (CHMI) is an important tool for assessment of the efficacy of novel malaria vaccines and drugs. As CHMI trials are carried out in a controlled environment, they allow unprecedented detailed evaluation of parasite growth and immunological responses, providing essential information for vaccine and drug development.

To date, modern CHMI studies have only been performed in countries where malaria is not endemic and involved volunteers who are malaria naïve. However, CHMI studies involving volunteers with prior exposure to malaria could be a valuable tool to accelerate malaria vaccine development.

The ability to perform CHMI studies in Africa would increase the international capacity for efficacy testing of malaria vaccines and allow earlier assessment of vaccine efficacy in the target, African population. CHMI trial centres in Africa would allow malaria endemic countries, which have the most to gain from malaria research, to influence the research agenda, to operate independently and to exercise ownership over key research pertinent to their health priorities.

We propose to conduct a CHMI study of 28 healthy adults with varying degrees of prior exposure to malaria in Kenya. We will assess parasite growth dynamics post CHMI and examine the relationship between this and laboratory assays of functional immunity to P. falciparum.