Posted 29 October 2014
By Louise Zornoza, RegLink News
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Swiss healthcare product regulator Swissmedic has approved an application to start a clinical trial for an experimental Ebola vaccine at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, the regulator announced on 27 October 2014.
Given the severity of the Ebola epidemic, the application, submitted at the end of September 2014, was handled by the agency as a priority. The trial, which will include 120 volunteers, is receiving considerable support from the World Health Organization (WHO) and continues a series of trials that began in the USA, the UK and Mali.
The vaccine, based on a genetically modified chimpanzee adenovirus (Zaire Ebola Chimpanzee Adenovirus, cAd3-EBO-Z), consists of viruses that have the genetic blueprint of a defined Ebola protein, but cannot replicate. It will initially be administered to healthy volunteers who will then be deployed as medical staff in the fight against the Ebola epidemic in West Africa. The trial will test the safety of the vaccine and its capacity to provide an immune response. The results from the CHUV trial will – together with the results of other centers involved – provide the basis for planning subsequent, much larger trials.
Since the vaccine is a genetically modified organism, Swissmedic has also consulted the Federal Office of Public Health, the Federal Office for the Environment and the Swiss Expert Committee for Biosafety.