A clinical trial to evaluate an experimental Ebola vaccine has been launched in Mali by the Center for Vaccine Development (CVD) at the University of Maryland School of Medicine (UM SOM), the Center for Vaccine Development of Mali (CVD-Mali) and Mali’s Ministry of Health.
The trial is one of two possible clinical studies of an Ebola vaccine candidate that could begin this month.
The Mali trial began Wednesday with the vaccination of the first subject, followed by two others yesterday. All three are Malian health care workers. In the coming weeks, 37 more health care workers will receive the vaccine, according to CVD.
“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 Samba Sow, M.D., Director General of CVD-Mali, in a joint statement issued today by the trial partners. CVD-Mali is a joint initiative between UM-SOM and Mali’s Ministry of Health.
“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,” Dr. Sow added.
Obtaining all ethical, regulatory agency, technical and administrative approvals needed for the clinical trial took two months. Ordinarily, CVD said, it takes between six to 11 months to advance a vaccine from animal-model research to to a clinical trial in a developing country where subjects are at risk of the natural disease.
The trials were designed and launched on an expedited basis given the seriousness of Ebola. According to World Health Organization (WHO) figures published Wednesday, 8,033 cases of the disease have been suspected or confirmed in the West Africa outbreak, along with 3,865 deaths. The deaths do not include the first U.S. death linked to the outbreak, Thomas Eric Duncan of Liberia, who died in Dallas on Wednesday.
None of the cases have occurred in Mali, but that nation is considered at high risk of having cases because it borders on Guinea, where the outbreak began late last year.
Investigators at the Vaccine Research Center (VRC) of NIH’s National Institute of Allergy and Infectious Diseases (NIAID) developed the vaccine, called cAd3. It consists of an adenovirus that was modified to prevent multiplication in humans, and which produces a single attachment protein of Ebola virus.
Immune responses directed against the protein have been shown to be highly protective in animal model challenge studies carried out under the highest level of physical containment – a response that researchers hope will be protective in humans as well.
“This research will give us crucial information about whether the vaccine is safe, well tolerated and capable of stimulating adequate immune responses in the highest priority target population, health care workers in West Africa,” CVD’s director, Myron M. Levine, M.D., D.T.P.H., said in a statement. “If it works, in the foreseeable future it could help alter the dynamic of this epidemic by interrupting transmission to health care and other exposed front-line workers.”
The clinical trial in Mali follows two months of work by an international consortium dedicated to advancing the vaccine into human clinical studies in West Africa. The consortium was assembled in August at the behest of the WHO, with members contributing more than $4.6 million in funding.
In addition to the WHO, CVD-UM SOM and CVD-Mali, the coalition includes the VRC, the Jenner Institute at the University of Oxford, which carried out clinical trials in U.K. adults paving the way for the African trial; GlaxoSmithKline (GSK) Biologicals, the vaccine’s manufacturer; and the Wellcome Trust, which funded the UK trial and will fund the trials in Mali.
Additional funding was provided by the Medical Research Council and the U.K. Department for International Development. MRC is expected to launch a second, parallel clinical trial in The Gambia, West Africa.
Preclinical 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. A 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.
The consortium is one of two teams looking to begin clinical studies for an experimental Ebola vaccine this month.
Separately, a team of U.S. and Canadian partners is days away from shipping between 800 and 1,000 vials of donated Ebola vaccine candidate to the WHO in Geneva.
The WHO is finalizing the legal agreement needed for it to take possession of the vials. “We are negotiating the final agreement and we should have it signed, I hope, by the beginning of next week. And we should be able to move the vaccine next week,” Marie-Paule Kieny, Ph.D., the WHO’s assistant director general for health systems and innovation, told The Canadian Press on Thursday.
The vials contain the vaccine candidate VSV-EBOV, developed by the Public Health Agency of Canada (PHAC), and licensed by PHAC to BioProtection Systems, a subsidiary of NewLink Genetics.
Brian Wiley, NewLink’s vice-president of business development, told The Canadian Press five clinical trials of the VSV-EBOV vaccine will soon be under way—two in the U.S., and one each in Germany, Switzerland and an unnamed African country that is not battling Ebola.
In separate announcements last month, NewLink Genetics won FDA approval to begin Phase I trials, while Johnson & Johnson said it was partnering with NIAID and Bavarian Nordicto develop an Ebola vaccine quickly enough to start human clinical trials early next year.