PfAMA1 - ASO2A Phase Ib Mali

Inventor: Dr Alan Thomas (BPRC, The Netherlands)
Product Leader: Florence Xhonneux, (Eurogentec, Belgium, http://biologics.eurogentec.com/)

A staggered clinical Phase Ib trial, sponsored by AMANET is currently being conducted at the Faculty of Medicine, University of Bamako, Mali.

Randomised controlled trial to evaluate the Safety and Immunogenicity of recombinant picha pastoris-expressed P. falciparum Apical Membrane Antigen 1 (PfAMA1-FVO[25-545]) versus tetanus toxoid, in healthy Malian adults in Bangiagara.

The initiation visit was conducted in May 2006. Ethical approval was granted in May 2007, and three doses have been administered to the 40 randomised volunteers. The safety follow-up is on going, and no Serious Adverse Events related to the vaccine have been reported. From the interim safety analysis, the safety profile of the vaccine is considered satisfactory and comparable to the tetanus toxoid vaccine.