Apical Membrane Antigen 1 in the Pichia pastoris system
Please see the background information for the on going project AMA1 - DiCo.
The original AMA1 proposal was received in response to the European Malaria Vaccine Initiative (EMVI) now European Vaccine Initiative call, 2000.
Extensive product development was carried out on AMA1 adjuvanted with Alhydrogel™ and Montanide ISA 720 between 2001 - 2004 under contracts with Eurogentec and Henogen. In 2005, a contract was signed with GlaxoSmithKline for development of AMA1 with their adjuvant ASO2.
A Phase I clinical trial took place in 2005 at the University of Nijmegen for the testing of AMA1 adjuvanted with Montanide.
The clinical trial was sponsored by European Malaria Vaccine Initiative (now European Vaccine Initiative)
Trial registration: Clinicaltrials.gov NCT00730782.
Assessment of the Safety and Immunogenicity of three Formulations of the RecombinantPichia pastoris Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]), Blood-stage malaria Vaccine in Healthy Dutch Adult Volunteers: a Phase I, Single-Blind, Randomised, Dose-escalating, Unicentre trial.
AMA1 - ASO2A Phase Ib Mali
Subsequently in 2007, a staggered clinical Phase Ib clinical trial was conducted at the Faculty of Medicine, University of Bamako, Mali, sponsored by the African Malaria Network Trust:
Randomised controlled clinical 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.
Clinical development was stopped in 2008 to pursue the current on going project Diversity Covering (DiCo) approach which addresses the allele diversity.