Ebola vaccine trials begin in Mali

The vaccine was developed by investigators at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland. 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 U.K. 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 U.K.(funder of the clinical trials in U.K. and Mali), with additional funding provided by the Medical Research Council (MRC U.K.., and the U.K. 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 eleven 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 to fully evaluate the promising vaccine,” said Professor Samba Sow, director general of CVD-Mali. “However, if it is eventually shown to work and if this information can be generated fast enough, it could become a public health tool to bring the current, and future, Ebola virus disease epidemics under control.”

“Malian health care workers are showing keen interest in participating in the clinical trial to help evaluate this vaccine,” said Dr. Milagritos Tapia, a key clinical investigator overseeing the trial in Mali.

“Ebola is among the most urgent international public health issues we are facing. This research will play a key role in helping to solve it,” said Dean E. Albert Reece, who is vice president of medical affairs at the University of Maryland and the John Z. and Akiko Bowers Distinguished Professor. “Dr. Levine, Dr. Sow and Dr. Tapia have done an extraordinary job, and are working hard to contribute their expertise to the worldwide effort to fight this virus.”

The release notes that pre-clinical research in primates by the VRC and Okairos, a biotechnology company acquired last year by GSK, indicate that the vaccine provides protection in non-human primates exposed to Ebola without significant side effects. The recent increase in funding for Ebola vaccine research is also enabling GSK to begin manufacturing at least 10,000 additional doses of the vaccine, even as the first clinical trials are occurring.

“This is impressive work by multiple groups to get this trial off the ground very quickly,” said Dr. Levine. “It is a testament to everyone’s commitment to fighting Ebola as aggressively as possible.”