Ebola vaccine from GSK to begin U.S. clinical trials within weeks-sources

NEW YORK Wed Aug 27, 2014 6:24pm EDT

NEW YORK Aug 27 (Reuters) - U.S. health officials will announce on Thursday that a human study of an Ebola vaccine made by GlaxoSmithKline will begin within a couple of weeks and not later this year as the company estimated originally, according to people familiar with the plans.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), will make the announcement as part of a previously scheduled briefing for reporters, the sources said.

In addition, a steering committee made up of senior officials from NIH and the Department of Defense last week approved 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 threats..

A feasibility analysis would determine which of the three labs, called Centers for Innovation in Advanced Development and Manufacturing (CIADM), have the capabilities to produce Ebola products including a special cocktail of antibodies like the experimental therapy from Mapp Biopharmaceutical that has been used in a few cases.

HHS is also engaging with a special network established last September to see if any of four contract pharmaceutical manufacturers have the capacity to support production of Ebola vaccines or therapies, the source said.

Called the "Fill Finish Manufacturing Network," it complements the CIADMs and comprises Cook Pharmica in Bloomington, Indiana; DSM Pharmaceuticals in Greenville, North Carolina; JHP Pharmaceuticals in Rochester, Michigan; and Nanotherapeutics in Alachua, Florida.

The trials being announced on Thursday would enroll healthy volunteers in the United States with the goal of determining whether the vaccine is safe and whether it provokes a protective immune response.

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.

A GSK spokeswoman confirmed that the trial would begin but declined to specify when.

There has been growing international pressure to accelerate the testing and production of experimental vaccines and treatments as the Ebola death toll in West Africa tops 1,400, making it the worst such outbreak on record. (Additional reporting by Ben Hirschler; Editing by Sonya Hepinstall)

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