Guidelines for the evaluation of Plasmodium falciparum vaccines in populations exposed to natural infection
English and French
This document combines and updates previous guidelines for the field evaluation of vaccines in malaria-endemic areas. It is addressed to national health authorities in malaria endemic countries and to researchers interested in the development and field evaluation of Plasmodium falciparum vaccines. The clinical and field trials considered in the guidelines are concerned with efficacy against natural challenge infection, as well as with safety and immunogenicity.
The guidelines are arranged into six sections:
- General background
- Information required concerning the vaccine before conducting an efficacy field trial
- Basic specifications of a Phase III field trial
- Criteria for the selection of study areas and background information required
- Methods of measurement, implementation, analysis
- Ethical considerations
The document was developed using contributions and comments from many different experts, listed in an annex.