Swissmedic has approved Ebola Vaccine Trial at Lausanne University Hospital by WHO Researcher to administer vaccine to 120 healthy volunteers.
The vaccine is based on a genetically modified chimpanzee
adenovirus ("ChAd-Ebola"; Chimpanzee-Adenovirus chAD3-ZEBOV). The trial
will test the safety of the vaccine and its capacity to induce an immune
response. Results from the CHUV trial will – together with the results
of other centres involved – provide the basis for planning subsequent
trials involving several thousand participants, and for choosing vaccine
dose-level for efficacy trials.
Developed by the US National Institute of Allergy and
Infectious Diseases (NIAID) and pharmaceutical company GlaxoSmithKline,
the vaccine consists of a virus that is rendered harmless and used as
genetic carrier for one Ebola protein. The application, submitted at the
end of September 2014, was handled as a priority, given the dimensions
of the Ebola epidemic in West Africa.
The World Health Organization (WHO) welcomes the approval by
Swissmedic, the Swiss regulatory authority for therapeutic products, for
a trial with an experimental Ebola vaccine at the Lausanne University
Hospital (CHUV). This marks the latest step towards bringing safe and
effective Ebola vaccines for testing and implementation as quickly as
possible.
Approval means that the vaccine can be used on approximately
120 individuals in Lausanne. The trial, which is receiving support from
WHO, is the latest in a series of trials that are ongoing in Mali, the
United Kingdom, and the United States.
The vaccine is based on a genetically modified chimpanzee
adenovirus ("ChAd-Ebola"; Chimpanzee-Adenovirus chAD3-ZEBOV). The trial
will test the safety of the vaccine and its capacity to induce an immune
response. Results from the CHUV trial will – together with the results
of other centres involved – provide the basis for planning subsequent
trials involving several thousand participants, and for choosing vaccine
dose-level for efficacy trials.
Developed by the US National Institute of Allergy and
Infectious Diseases (NIAID) and pharmaceutical company GlaxoSmithKline,
the vaccine consists of a virus that is rendered harmless and used as
genetic carrier for one Ebola protein. The application, submitted at the
end of September 2014, was handled as a priority, given the dimensions
of the Ebola epidemic in West Africa.
The trial is one of two in Switzerland coordinated by WHO. A
second vaccine, rVSV-ZEBOV, is to be tested at the Geneva University
Hospitals, concurrent to the Lausanne trial.
“These are dosing and safety trials being held in advance of
Phase II and III trials currently scheduled for late 2014-early 2015,”
says Marie-Paule Kieny, Assistant Director-General for Health Systems
and Innovation at WHO. “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.”
Trials in Lausanne will begin this week, with first results expected in December 2014.
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