* 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,
By Ben Hirschler and Sharon Begley
LONDON/NEW YORK, Aug 28 An experimental Ebola
vaccine from GlaxoSmithKline is being fast-tracked into
human studies and the company plans to build a stockpile of up
to 10,000 doses for emergency deployment, if results are good.
The research work is being accelerated with funding from an
international consortium, reflecting mounting concern over the
worst outbreak of the disease that has killed more than 1,500
people in West Africa.
GSK's candidate vaccine, being co-developed with the U.S.
National Institutes of Health (NIH), is expected to be given to
healthy volunteers in Britain and the United States from about
mid-September, with the programme then being extended to Gambia
Britain's biggest drugmaker said on Thursday the Phase I
trials would start as soon as they received ethical and
The NIH's National Institute of Allergy and Infectious
Diseases is also working on a wider programme of clinical
trials, including tests of a version of the GSK vaccine that may
fight a second strain of Ebola, as well as the West African one.
In addition, U.S. researchers plan human tests of a vaccine
developed by Canadian government scientists, which has been
licensed to NewLink Genetics.
The trials being announced will enroll healthy volunteers
with the goal of determining whether the vaccine is safe and
whether it provokes a protective immune response.
The aim is to complete these tests by the end of 2014, after
which vaccines could be deployed on an emergency basis.
RACE TO TEST
In a grim assessment of the deadly disease, the World Health
Organisation said on Thursday that the current Ebola outbreak
was continuing to accelerate and could infect more than 20,000
Jeremy Farrar, director of the Wellcome Trust medical
charity, which is helping to fund the vaccine trials, said the
effectiveness of vaccines and drugs could only be assessed
during epidemics, so it was vital to test products now.
GSK plans to begin making up to about 10,000 additional
doses of its vaccine at the same time as the initial clinical
trials, so if they are successful vaccine could be made
available immediately for an emergency immunisation programme.
NewLink has also contracted for the manufacture of increased
supplies of its vaccine.
A steering committee made up of senior officials from NIH
and the U.S. Department of Defense also approved last week the
first step toward using three advanced laboratories to
manufacture Ebola vaccines and treatments, a person familiar
with the planning told Reuters.
The three labs, in Texas, Maryland and North Carolina, were
set up in 2012 by the U.S. Department of Health and Human
Services (HHS) in partnership with private industry to respond
to pandemics or chemical, biological, radiological or nuclear
The GSK vaccine consists of a common cold virus, called an
adenovirus, that has been engineered to carry two genes of the
Ebola virus. Animal testing has shown that when the adenovirus
infects cells the Ebola genes produce harmless proteins that
stimulate the immune system to produce antibodies to Ebola.
GSK acquired the vaccine after buying Swiss-based biotech
company Okairos for 250 million euros ($330 million) last year.
($1 = 0.7591 Euros)
(Editing by Sonya Hepinstall and David Clarke)