ROCKVILLE – More than a year after the Ebola virus resurfaced in Africa, a successful vaccine might become a reality in Montgomery County.
“The pre-clinical data is very, very promising. I have a great deal of hope,” said Dr. Stephan A. Bart, president and chief medical officer of Optimal Research and principal investigator of a trial that he says is “leading the U.S. initiative for the development of this important vaccine.”
According to Bart, the vaccine they are testing proved to be 100 percent effective in pre-clinical trials.
Optimal Research announced the start of their Phase 1 clinical trials, which will occur in Rockville, last week. Recruitment for the trial is currently underway and enrollment is expected to be completed by the end of February. The first volunteers are planned to receive their initial vaccine dose by the end of this month.
The purpose of the study is to test whether exposure to two vaccine regimens, MVA-BN-filo and AD26. ZEBOV, will safely provoke an immune response in the body.
The study, funded by the biopharmaceutical company Crucell, will conclude after a year at which point Bart said Crucell will “rapidly look at the data we generate from this study” and determine whether to expand the testing into more endemic areas such as Africa.
Similar vaccine trials are ongoing at the National Institutes of Health (NIH) in Bethesda and at Walter Reed Army Institute of Research in Silver Spring. According to NIH, NIH and the U.S. Department of Defense are collaborating on the simultaneous trials.
The most recent trial at NIH began in September 2014. The most recent study at Walter Reed began in October.
According to NIH, the current trial is testing a vaccine based on a type of chimpanzee “cold” virus, called chimp adenovirus type 3 (cAd3). The virus is then used as a carrier to deliver segments of genetic material derived from two Ebola virus species: Zaire Ebola and Sudan Ebola. The Zaire species of the virus caused the current Ebola outbreak in West Africa.
Since the trials have progressed, NIH officials said the vaccine has been well-tolerated by all 20 volunteers in the study and that all 20 have produced immune system responses.
The vaccine at Walter Reed has yielded similar results. Doctor Debra L. Yourick, director of Science Education and Strategic Communications, said all the subjects in their study had completed the immunization stage and have moved on to the follow-up phase.
Yourick said these vaccines would usually be tested sequentially, not simultaneously as it is being done now. But considering the circumstances, she said, a lot of time and money has been spent to get the vaccinations ready for use.
Yourick said the difference between the vaccine at Walter Reed and the one at NIH is that the Walter Reed vaccine is a vesicular stomatitis virus Ebola vaccine (called VSV-Zebov). The virus belongs to the Rhabdoviridae family, the same family rabies belongs to.
“They’ve taken a virus that isn’t a natural human pathogen and pulled one gene from that and created a covering that looks like the Ebola viral vaccine coding,” Yourick said.
Yourick said the hypothesis is that the virus is training the body to know what the Ebola virus looks like so that if the human came in contact with the virus it would be able to fend it off.
Given the results, Yourick said the vaccine looks sufficiently safe. When tested on non-human primates Yourick said the data was “positive.”
Yourick emphasized there is no risk of anyone contracting Ebola as a result of these trials.
As of now, the National Institute of Allergy and Infectious Disease, a sub-body of NIH, is in active discussions with Liberian officials and other partners about next-stage vaccine testing in West Africa.