Swissmedic approves an Ebola vaccine trial at the CHUV in Lausanne
(Last modification 29.10.2014)
Bern, 28.10.2014 - On 27 October 2014, Swissmedic approved the application for a trial with an experimental Ebola vaccine at the Lausanne University Hospital (CHUV). It will be conducted on 120 volunteer participants. The trial, which is receiving considerable support from the World Health Organization (WHO), continues the series 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), will initially be administered to healthy volunteers who will 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 centres involved – provide the basis for optimising the planning of subsequent trials involving several thousand participants and for conducting them safely.
The vaccine consists of viruses that cannot replicate, which are populated by the genetic blueprint of a defined Ebola protein. Since this vaccine is a genetically modified organism, Swissmedic – as required by its legal mandate – has also consulted the Federal Office of Public Health, the Federal Office for the Environment and the Swiss Expert Committee for Biosafety. The application, submitted at the end of September 2014, was handled as a priority given the dimensions of the Ebola epidemic.
Clinical trials are used for the systematic gathering of information on medicinal products when used on humans. Clinical trials with medicinal products in Switzerland may only be carried out with the approval of Swissmedic and the competent Ethics Committee.
As the enforcement authority, Swissmedic examines the documentation submitted with regard to whether the quality and safety of the trial product is sufficient in order to permit its use on humans. The Ethics Committee examines the ethical aspects of the trial and issues related to the safety of the trial participants. The trial may only begin when both authorities have approved it.
During the trials, adverse reactions and amendments must always be reported to the Ethics Committees and/or to Swissmedic. In 2013, 212 applications for clinical trials with medicinal products were submitted, and 205 of them were approved.
Address for enquiries
Swissmedic, Swiss Agency for Therapeutic Products
Peter Balzli, Acting spokesman
+41 58 462 02 76
media@swissmedic.ch
Publisher
Swiss Agency for Therapeutic Products
http://www.swissmedic.ch/?lang=2
