Clinical Trials
Mali, West Africa
Much effort has been undertaken to develop a vaccine testing site in Mali, West Africa. To date, one Phase I trial has been completed, and one Phase I/II trial of an MVDB vaccine is near completion. An additional Phase I trial began in August 2007.
Our vaccine trials in Mali are sponsored and monitored by the NIAID intramural Regulatory Compliance and Human Subjects Protection Branch (RCHSPB). Ethical reviews are conducted by both the NIAID Institutional Review Board (IRB) and the ethical review committee of the Faculty of Medicine, Pharmacy, and Dentistry at the University of Bamako, which has a Federal-Wide Assurance (FWA #0001769) from the U.S. Office of Human Research Protections.
Prior to the initiation of every vaccine trial in Mali, permission for the study is also obtained from the community leaders at the trial site, in accordance with Malian traditions and customs. Furthermore, individual informed consent is also obtained and documented according to both U.S. and international regulations and guidelines.
Years of preparation have been required prior to conducting Phase I and II field trials in Mali. The primary vaccine trial sites were developed in collaboration with the Malaria Research and Training Center (MRTC) at the University of Bamako in Mali as a result of MVDB’s longstanding partnership with researchers at this institution.
Preparation for large-scale Phase IIb field trials in Mali, comprising 300 – 400 children per trial, has involved several components:
- Assembling a highly trained and qualified team of Malian investigators and support staff
- Investing in physical infrastructure
- Upgrading of local Malian laboratory facilities, both research and clinical
- Conducting preparatory studies to establish the baseline epidemiology of malaria in the area and population to be studied
These preparations have been divided into two phases for both logistical and budgetary reasons:
- Establishment of the capacity to perform Phase I studies
- Enhancement of the capability to perform larger Phase II studies
A vaccine testing center in the Malian village of Donéguébougou has been developed, is fully operational, and has successfully completed two Phase I trials. A second, larger vaccine testing site in Bancoumana is also fully developed and is currently the site of the first Phase I/II blood-stage vaccine trial in Mali.
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