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UPDATE 1-Ebola vaccine from GSK fast-tracked into clinical trials

Thu, 28th Aug 2014 11:06

* Trials to vaccinate healthy volunteers from mid-September

* Planned stockpile of up to 10,000 doses for early use

* GSK working with U.S. NIH and international consortium

* U.S. researchers also testing Canadian Ebola vaccine (Updates with further details on clinical trial programme,different vaccines)

By Ben Hirschler and Sharon Begley

LONDON/NEW YORK, Aug 28 (Reuters) - An experimental Ebolavaccine from GlaxoSmithKline is being fast-tracked intohuman studies and the company plans to build a stockpile of upto 10,000 doses for emergency deployment, if results are good.

The research work is being accelerated with funding from aninternational consortium, reflecting mounting concern over theworst outbreak of the disease that has killed more than 1,500people in West Africa.

GSK's candidate vaccine, being co-developed with the U.S.National Institutes of Health (NIH), is expected to be given tohealthy volunteers in Britain and the United States from aboutmid-September, with the programme then being extended to Gambiaand Mali.

Britain's biggest drugmaker said on Thursday the Phase Itrials would start as soon as they received ethical andregulatory approvals.

The NIH's National Institute of Allergy and InfectiousDiseases is also working on a wider programme of clinicaltrials, including tests of a version of the GSK vaccine that mayfight a second strain of Ebola, as well as the West African one.

In addition, U.S. researchers plan human tests of a vaccinedeveloped by Canadian government scientists, which has beenlicensed to NewLink Genetics.

The trials being announced will enroll healthy volunteerswith the goal of determining whether the vaccine is safe andwhether it provokes a protective immune response.

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

RACE TO TEST

In a grim assessment of the deadly disease, the World HealthOrganisation said on Thursday that the current Ebola outbreakwas continuing to accelerate and could infect more than 20,000people.

Jeremy Farrar, director of the Wellcome Trust medicalcharity, which is helping to fund the vaccine trials, said theeffectiveness of vaccines and drugs could only be assessedduring epidemics, so it was vital to test products now.

GSK plans to begin making up to about 10,000 additionaldoses of its vaccine at the same time as the initial clinicaltrials, so if they are successful vaccine could be madeavailable immediately for an emergency immunisation programme.

NewLink has also contracted for the manufacture of increasedsupplies of its vaccine.

A steering committee made up of senior officials from NIHand the U.S. Department of Defense also approved last week thefirst step toward using three advanced laboratories tomanufacture Ebola vaccines and treatments, a person familiarwith the planning told Reuters.

The three labs, in Texas, Maryland and North Carolina, wereset up in 2012 by the U.S. Department of Health and HumanServices (HHS) in partnership with private industry to respondto pandemics or chemical, biological, radiological or nuclearthreats..

The GSK vaccine consists of a common cold virus, called anadenovirus, that has been engineered to carry two genes of theEbola virus. Animal testing has shown that when the adenovirusinfects cells the Ebola genes produce harmless proteins thatstimulate the immune system to produce antibodies to Ebola.

GSK acquired the vaccine after buying Swiss-based biotechcompany Okairos for 250 million euros ($330 million) last year. ($1 = 0.7591 Euros) (Editing by Sonya Hepinstall and David Clarke)

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