Over the past six years, AMVTN has established itself as a leading pan-African network building human capacity in malaria vaccine research, development and clinical trials. AMVTN's courses, workshops and seminars are oversubscribed, reflecting the need for continuous and expanded human capacity building. The proposed activities will benefit African prospective study sites by complementing a recent grant of €3.1 million by the Government of the Netherlands to AMVTN's essential capacity strengthening in health research ethics, GCP, GLP, vaccinology, monitoring, data management, exchange of clinical trialists and establishment of an essential malaria vaccine database. Collective strengths and expertise of African and European scientists will ensure smooth cooperation and adherence to ethical principles in the evaluation of intervention trials.
Malaria is the leading public health enemy in sub-Saharan Africa. Current tools for its management, prevention and control are turning blunt. Malaria vaccines are badly needed, promising new tools. The aim of this concerted action is:
1) to consolidate, strengthen and expand the already existing platform for the proper planning and effective coordination of clinical and field evaluation of malaria vaccines in Africa
2) to ensure smooth transfer of newly manufactured malaria vaccine candidates (after phase Ia testing) to African malaria vaccine trial sites through the collaboration of an African malaria network and participating African and European institutions
3) to build capacity, particularly at prospective trial sites, in the form of training workshops (GLP, GCP, SOP, ethics, vaccinology, data management, etc.), exchange of trialists and data exchange
4) to further develop AMVTN's secretariat to a focal point for information and exchange of data on malaria vaccine trial activities.
The following training workshops will be organised by this concerted action: GLP and SOP, Health Research Ethics, GCP, Data Management in Intervention Trials, Vaccinology in Developing Countries, Operations of Ethics Review Committees, Strengthening Principal Investigators and GCP for Clinical Monitors. Moreover, AMVTN will organise: Exchange of Clinical Trialists - between the trial sites in Africa and clinical trial centres in Africa and Europe; Central Data Management - AMVTN will gradually build up a central database on malaria vaccine trials, reviews, results and impact; Organise Online Subscription to Journals; Strengthen the Network Secretariat. The network recently received a €3.1 million grant to strengthen prospective African malaria vaccine study sites by undertaking site characterisation, strengthening and initiation of malaria vaccine testing. The grant will complement the proposal.
The knowledge and skills gained will ensure adherence to established international standards of ethics, GCP, data management and the operationalisation, monitoring and evaluation of intervention trials. By the exchange of trialists, African investigators will gain skills from European and other African experts, trial institutions will share trial data, at least ten potential institutions will gain internet connectivity and the network secretariat will be strengthened.
Statens Serum Institut
Office of International Health
Tel: +45 32 683188
Fax: +45 31 683228
African Malaria Vaccine Testing Network
Dar es Salaam
Tel: +255 22 270 0018
Fax: +255 22 270 0380