January 5, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
The clinical trial of the Merck -NewLink Genetics ebola vaccine, which was suspended in mid-December over concerns around side effects on patients, has resumed at University Hospitals of Geneva (HUG), the institution said in a statement. Participants in the trial will now receive a lower dose, which “should be better tolerated by volunteers and will hopefully trigger the production of enough antibodies,” according to the statement.
The trial was suspended after four of 59 volunteers complained of joint pain similar to rheumatism 10 to 15 days after the vaccine was administered. Further observations indicated that a total of ten patients experienced inflammation. Joint inflammation after vaccination with a live vaccine is a “known phenomenon,” HUG stated. “These symptoms quickly disappeared, even without treatment, and not a single volunteer had to miss work or to be hospitalized.
In the wake of these results, Swissmedic, the Swiss regulatory agency, and other ethics committees approved the resumption of the trial. BioSpace has been tracking the progress of every Ebola vaccine in clinical trials, a cataloguing which can be found here.
In the initial trial, during which 59 of the 115 total volunteers were vaccinated, volunteers received a test dose of 10 or 50 million particles. The remaining volunteers in the trial will receive a test dose of 300,000 particles, according to HUG. “Fortunately,” it stated, “the vaccine candidate seems able to induce the production of antibodies at lower doses than those previously used” during the trial.
Injections will resume today for the remaining volunteers in groups of 15 and will continue until the end of January. Final results of the trial are expected in March 2015. The Geneva team is “constantly exchanging information,” HUG stated, with teams conducting Ebola vaccine studies in Canada, Gabon, Germany and the United States.
The vaccine used in the trial was developed by the Public Health Agency of Canada (PHAC), and licensed to a wholly owned subsidiary of NewLink in 2010. In November 2014, BioSpace reported that NewLink and Merck signed an agreement to develop, manufacture and distribute this vaccine, now referred to as the Merck-NewLink Ebola vaccine candidate.
NewLink and Merck announced in mid-December that a division of the United States Department of Health and Human Services (HHS) awarded the companies a $30 million contract for the manufacturing and development of their Ebola vaccine candidate, reported BioSpace.
According to the World Health Organization and the U.S. Centers for Disease Control and Prevention, Ebola has killed more than 8,000 people in the latest outbreak, with Sierra Leone and Liberia the hardest of the nine countries thus far affected.
