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Pin to quick picksGlaxosmithkline Share News (GSK)

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UPDATE 1-First UK volunteer gets experimental GSK Ebola shot in trial

Wed, 17th Sep 2014 16:00

(Adds details, quotes from lead investigator, background)

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 theU.S. National Institutes of Health, has also been given to 10volunteers taking part in a similar separate trial in the UnitedStates, and so far there were no signs of any serious adversereactions, doctors said.

The vaccine being tested in the UK is designed tospecifically target the Zaire strain of Ebola, the onecirculating in the West Africa epidemic, the worst Ebolaoutbreak recorded.

Since the shot contains no infectious Ebola virus material,only one of its genes, experts say there are no concerns thatany of the subjects will contract the deadly disease.

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.

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.

Professor Adrian Hill, a vaccine researcher at the JennerInstitute at Oxford University who is leading the trial, saidthe volunteer - a 48-year-old former nurse - had experienced noproblems since she was given the vaccine early on Wednesday andwas "doing very well at her two-hour check".

The aim is to recruit a total of 60 people for the UK trialand complete the tests by the end of 2014, after which thevaccines could be deployed on an emergency basis.

Study data from an animal trial of an Ebola vaccine similarto this one showed that it was effective for at least five weeksin lab monkeys but required boosting with an additional vaccineto extend its protection to 10 months.

Hill said he has no shortage of volunteers, with some 200people having contacted him so far. These are being screened, hesaid, to make sure they fit the required age and healthprofiles, and to ensure they are able to return for a total ofnine check-ups over the duration of the trial.

"I'm pretty confident that the safety is going to be ok, butthe big question is, will it work? In other words, will theimmune response that we get be strong enough to prevent Ebolainfection?" Hill said in a telephone interview.

"We need to find out whether what works in monkeys alsolooks good in humans."

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." (Editing by Janet Lawrence and Sonya Hepinstall)

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