Guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum, Annex 3, TRS No 980

Overview

These Guidelines are intended to provide guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the quality (including the production, quality control, characterization and stability), and nonclinical and clinical aspects of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum.

Various approaches to the development of malaria vaccines are being investigated that employ different production platforms, and target different stages of the life-cycle of malaria parasites. As of 2012, only one candidate vaccine – RTS,S/AS01, a recombinant P. falciparum malaria vaccine produced in yeast that targets the pre-erythrocytic stage of the parasite – was under evaluation in phase III clinical trials (1). In early clinical trials, this vaccine demonstrated some degree of efficacy in reducing all episodes of clinical malaria (2–4).

These Guidelines consist of three technical sections – Part A: Guidelines on manufacturing and control; Part B: Non-clinical evaluation; and Part C: Clinical evaluation. These three sections differ somewhat in their scope to reflect the different stages of vaccine development, and the diversity of production platforms and vaccine targets. This document should be read in conjunction with other relevant WHO Guidelines, including those on the nonclinical (7) and clinical (8) evaluation of vaccines.

Full version of WHO Technical Report Series No. 980