GENEVA, Dec. 11 (Xinhua) -- The Geneva university hospital on Thursday suspended the injection of the experimental VSV-ZEBOV Ebola vaccine, which currently under clinical trials in the hospital, due to joint pain complaints.
In early November, Swissmedic, the Swiss regulatory authority for therapeutic products, authorized a second trial with experimental VSV-ZEBOV vaccine. It was developed by the Public Health Agency of Canada based on the virus that causes vesicular stomatitis, a disease affecting animals.
The clinical trial, led by Geneva university hospital, planned to text approximately 115 volunteers in Geneva on the safety and efficacy of the vaccine.
Since Nov. 10, a total of 59 volunteers took part in the clinical trial of the experimental vaccine. All of these volunteers are in good health and being monitored regularly by the team in charge of the study.
However, close monitoring of the volunteers by the study team identified four cases of mild joint pains (in the hands and feet), 10 to 15 days after receiving the injection.
"These symptoms were not part of the expected side effects and were not included in the prior information given to volunteers, since this vaccine is being tested on humans for the first time," the hospital said in a statement.
As a precautionary measure, the study team has declared a pause in the injections and no injections will take place next week.
This pause came one week earlier than a scheduled pause in the vaccination series. The available time will serve to gather more information and exchange it with the other teams that are testing the same experimental vaccine.
The hospital said the onset of joint pain after infection or vaccination is very common. However, it deserves to be carefully studied in order to update the information which is provided to the volunteers. The temporary interruption of a clinical trial is a standard precautionary measure in such cases.
The VSV-ZEBOV Geneva study team is constantly exchanging information with teams conducting similar studies in the United States, Canada, Germany and Gabon. Up to now, these teams have not observed inflammatory symptoms among their volunteers.
In Geneva, vaccinations will resume on Jan. 5 next year with maximum 15 volunteers per week in order to ensure optimal monitoring conditions.
