Towards an African-driven malaria vaccine development program: history and activities of the African Malaria Network Trust (AMANET).

The African Malaria Network Trust (AMANET), whose mission is to promote capacity strengthening of African malaria research institutions, was founded in 2002 and is currently focusing on malaria vaccine development. AMANET has trained over 900 African malaria researchers at workshops relevant to clinical trials of candidate malaria vaccines that will meet scientific, ethical, and international Good Clinical Practice standards. African centers selected for developing malaria vaccines initially undergo a needs assessment, followed by filling gaps in short- and long-term training, provision of essential equipment, and infrastructure improvement. Four centers from different malaria ecoepidemiologic settings are being strengthened; two of these have been approved for carrying out malaria vaccine trials. Researchers from prospective trial sites are mentored at northern institutions undertaking Phase 1a and/or 2a trials; five researchers are undergoing doctoral training. AMANET has sponsored one successful Phase 1b trial; three more are underway. Expert site audits will precede launch of phase 2b trials. Several lessons have been learned: the building of comprehensive capacity, essential for undertaking internationally acceptable trials including their sponsorship, is complex and costly. AMANET has spent over US$ 1 million on capacity strengthening of its leading trial center. Despite the high costs, development of three other sites is underway and there are plans to develop two more sites. To succeed, genuine north-south collaboration based on mutual trust and sharing of available information and responsibilities has been essential. AMANET as a sponsor has assumed roles usually reserved for the pharmaceutical industry, yet is operating where regulatory authorities are generally weak or wanting.