Following consultations with members of the core research groups concerned with malaria vaccine development, this consortium (EMVI and AMVTN) proposes to convene a series of workshops with the participation of the pharmaceutical industry. The aim is to develop standardised trial protocols for phase I and possible phase II clinical trials of pre-erythrocytic, erythrocytic and transmission-blocking malaria vaccine to be tested in a European facility. The development of standardised clinical protocols will follow the guidelines set forth by the international congress on harmonisation (ICH), and will involve consultations with the European agency for the evaluation of medicinal products and assistance from the European forum for good clinical practice, especially the chair concerning ethics.
Supplementary funding is requested to meet the cost of travel and accommodation for European experts and experts from the African malaria vaccine testing network (AMVTN) attending workshops to be held during the first six months of the year 2000 in Europe. The objectives are to develop common clinical trial protocols for at least phase I clinical trials, possibly also for phase II for pre-erythrocytic, erythrocytic and transmission-blocking vaccines. This will be in preparation for the development of clinical trial protocols in Africa.
The workshops will review and discuss the various clinical trial protocols employed in Australia, USA and Latin America, and by industry in malaria vaccine clinical trials. During the workshop sessions, the participants will receive an update on current good practice in clinical trials (GCP) from the European forum for good clinical practice, especially from the chair of the ethics working party. Regulatory issues will be sought and these will be addressed by an expert from the European Agency for Medicinal Evaluation, London. Various issues concerning confidentiality, property rights, informed consent in medical research, ownership and use of data, culture collections and data banks will be discussed and included in the draft protocol. The development of the clinical trial protocols will be guided by ‘international ethical guidelines for biomedical research involving human subjects’ (1993) and the world medical associations' declaration of Helsinki, latest version 1996. A secretary will be appointed for each of the workshops who will be responsible for drafting reports and having them approved by the participants. Based on the aforementioned guidelines, the outcome of the discussions and the reports, the secretary will draft clinical trial protocols and then have them approved by the participants. Final protocols will be submitted to the commission, and will be introduced on the home pages of EMVI and AMVTN to guide proposers for clinical trials, and to alleviate the workload involved in proposal development. The protocols will form models for the development in Africa of trial protocols tailored to identified specific needs and problems under various transmission conditions.
The workshops will lead to the establishment of common criteria and standards for phase I human clinical trials in malaria vaccines and possibly also for phase II clinical trials for pre-erythrocytic, erythrocytic and transmission blocking vaccine. This will accelerate European and global efforts to contribute to the development of much needed malaria vaccine. The participation of AMVTN and industry will ensure industrial applicability and relevance to further clinical trials in Africa.
Statens Serum Institut,
Office of International Health
Statens Serum Institut Artillerivej
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