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Pin to quick picksGlaxosmithkline Share News (GSK)

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First UK volunteer gets experimental GSK Ebola shot in trial

Wed, 17th Sep 2014 12:18

By Kate Kelland

LONDON, Sept 17 (Reuters) - The first volunteer in afast-tracked British safety trial of an experimental Ebolavaccine made by GlaxoSmithKline received the injectionon Wednesday, trial organisers said.

The candidate Ebola vaccine, which GSK co-developed with theUnited States National Institutes of Health, has also been givento 10 volunteers taking part in a separate trial in the UnitedStates, and so far there were no signs of any serious adversereactions, doctors said.

The vaccine is designed to specifically target the Zairestrain of Ebola, the one circulating in the West Africaepidemic, the worst Ebola outbreak recorded.

Since the vaccine contains no infectious Ebola virusmaterial, only one of its genes, experts say there are noconcerns that any of the subjects will contract the deadlydisease.

Latest data from the World Health Organisation (WHO) show about 2,500 people have died of Ebola in an outbreak thatstarted in March and has infected almost 5,000 people in Guinea,Sierra Leone, Liberia and Nigeria.

The British trial is being run by a team at OxfordUniversity.

A spokeswoman for the Oxford team said the first volunteerin the UK trial was vaccinated early on Wednesday, but gave nofurther information. She said more details would be given later.

Dr. Anthony Fauci of the National Institute of Allergy andInfectious Diseases told a U.S. Senate panel on Tuesday that "nored flags" indicating serious adverse reactions have been foundin the 10 healthy volunteers vaccinated there so far.

The trials are seeking to determine not only whether thevaccine is safe, or causes adverse side effects, but alsowhether it triggers the production of antibodies against theEbola virus.

The aim is to complete the tests by the end of 2014, afterwhich vaccines could be deployed on an emergency basis.

GSK says it plans to begin making up to about 10,000 dosesof the vaccine at the same time as the initial clinical trials,so that if they are successful, the vaccine could be madeavailable immediately for an emergency immunisation programme.

Ben Neuman, a virologist at the University of Reading who isnot involved in the vaccine studies, said it was important notto get ahead of the results.

"There is clearly a need for this vaccine, but what is notclear is whether it will work well enough to protect someonefrom Ebola," he said.

He said the experimental shot "uses some of the bestavailable technology to give the immune system a good long lookat its target, a small but vitally important part of the virus",but added: "We won't really be able to tell whether the vaccineworks until it is tested on the ground in West Africa."

Study data from an animal trial of an Ebola vaccine similarto this GSK one showed that it was effective for at least fiveweeks in lab monkeys but required boosting with an additionalvaccine to extend its protection to 10 months. (Editing by Janet Lawrence)

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