The Swiss medical authorities have approved the application for a trial with an experimental Ebola vaccine at the Lausanne University Hospital (CHUV). The first volunteers are expected to be vaccinated on October 31.This content was published on October 28, 2014 - 11:22
The trial, which is receiving considerable support from the Geneva-based World Health Organization (WHO), continues the series that began in the United States, Britain and Mali, said a statementExternal link from the Swiss Agency for Therapeutic Products (Swissmedic) on Tuesday.
It added that the application for the trial, made last month, “was handled as a priority given the dimensions of the Ebola epidemic”. The virus has infected more than 10,000 people and killed almost 5,000 in West Africa, according to the World Health Organization's latest figures.External link
The trial concerns a vaccine developed in the US.As soon as the approval was received on Monday, the order was given to fly in the doses, Blaise Genton, director of the infectious disease service at the CHUVExternal link, told reporters at a press conference in Lausanne on Tuesday. The first volunteers – there are 120 in all – will be vaccinated on Friday. All are expected to have received the vaccine by Christmas.
The volunteers include a group that will be deployed as medical staff in the fight against the Ebola epidemic in West Africa, explained Genton. The other group will stay in Switzerland. There will also be a small placebo control group.
The vaccine consists of a virus that has been rendered harmless and is used as genetic carrier for one Ebola protein (genetically modified chimpanzee adenovirus: Zaire Ebola Chimpanzee Adenovirus, cAd3-EBO-Z).
Participants will be monitored for six months to determine both the safety and efficacy of the vaccine. The first results are expected in December 2014.
There are currently no proven drugs or vaccines against Ebola so pharmaceutical companies, with the backing of governments, international organisations and donors, have been fast-tracking the normal lengthy development process.
The vaccine being tested at the CHUV has been developed by the US National Institute of Allergy and Infectious Diseases (NIAID) and pharmaceutical company GlaxoSmithKline (GSK). The results will, along with the results of other centres involved, provide the basis for optimising the planning of subsequent larger trials and for choosing vaccine dose-level for efficacy trials.
Experts say it is not possible to say exactly when a vaccine might be ready, but GSK has estimated that it might be able to make one million doses of its vaccine a month by December 2015.
A second vaccine under development comes from Canada and is set to be tested at the University Hospital of Geneva, once approval from Swissmedic has been issued.
The WHO, which is coordinating efforts to find an Ebola vaccine, said that it welcomed Swissmedic’s approval of the Lausanne trial and the prospect of the second, concurrent trial in Geneva.
“These are dosing and safety trials being held in advance of Phase II and III trials currently scheduled for late 2014-early 2015,” said Marie-Paule Kieny, Assistant Director General for Health Systems and Innovation at WHO, in a statementExternal link.
“If shown to be safe and effective, either of the vaccines could be scaled up for production during the first quarter of next year, with millions of doses produced for wide distribution in high-risk countries.”
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