University of Maryland School Of Medicine and Malian Ministry of Health Begin Human Trials of Experimental Ebola Vaccine in Mali, West Africa
First Study of a Promising Ebola Vaccine Undertaken in West Africa
…The Center for Vaccine Development (CVD) at the University of Maryland School of Medicine announced that, in conjunction with its sister institution, The Center for Vaccine Development of Mali (CVD-Mali) and the Ministry of Health of Mali, initiation of a clinical trial in health care workers (and other front-line workers) to “evaluate a promising experimental Ebola vaccine.”
The trial began on Wednesday, October 8 with the vaccination of the first subject, followed by two additional participants today (October 9), all three being Malian health care workers. In the coming weeks 37 more health care workers will receive the vaccine…
…The vaccine was developed by investigators at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. The clinical trial in Mali brings to fruition two months of work by a consortium dedicated to move the candidate Ebola vaccine (which prior to September had been tested only in animals but not in humans) into clinical studies in West Africa. The consortium, assembled in mid-August at the behest of the World Health Organization (WHO), included, besides WHO, the VRC (which developed the vaccine), the Jenner Institute at the University of Oxford (which carried out clinical trials in UK adults paving the way for the African trial), the CVD-UM SOM and CVD-Mali (carrying out the first clinical trial of the vaccine in West Africa), GlaxoSmithKline (GSK) Biologicals (manufacturer of the vaccine) and the Wellcome Trust, UK (funder of the clinical trials in UK and Mali), with additional funding provided by the Medical Research Council (MRC), UK and the UK Department for International Development (DFID).
In addition, the MRC Unit-The Gambia is expected soon to initiate a second, parallel clinical trial in The Gambia, West Africa. Ordinarily it would take between six to 11 months to obtain all necessary ethical, regulatory agency, technical and administrative approvals needed to transition a vaccine from research in animal models to a clinical trial in a developing country where subjects are at risk of the natural disease. In this instance, with all consortium members working in unison, it took two months…
“This is just the critical first step in a series of additional clinical trials that will have to be carried out.”