By Sharon Begley
NEW YORK, Aug 27 (Reuters) - U.S. health officials willannounce on Thursday that a human study of an Ebola vaccine madeby GlaxoSmithKline will begin within a couple of weeksand 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 theannouncement as part of a previously scheduled briefing forreporters, the sources said.
In addition, a steering committee made up of seniorofficials from NIH and the Department of Defense last weekapproved the first step toward using three advanced laboratoriesto manufacture 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..
A feasibility analysis would determine which of the threelabs, called Centers for Innovation in Advanced Development andManufacturing (CIADM), have the capabilities to produce Ebolaproducts including a special cocktail of antibodies like theexperimental therapy from Mapp Biopharmaceutical that has beenused in a few cases.
HHS is also engaging with a special network established lastSeptember to see if any of four contract pharmaceuticalmanufacturers have the capacity to support production of Ebolavaccines or therapies, the source said.
Called the "Fill Finish Manufacturing Network," itcomplements the CIADMs and comprises Cook Pharmica inBloomington, Indiana; DSM Pharmaceuticals in Greenville, NorthCarolina; JHP Pharmaceuticals in Rochester, Michigan; andNanotherapeutics in Alachua, Florida.
The trials being announced on Thursday would enroll healthyvolunteers in the United States with the goal of determiningwhether the vaccine is safe and whether it provokes a protectiveimmune response.
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.
A GSK spokeswoman confirmed that the trial would begin butdeclined to specify when.
There has been growing international pressure to acceleratethe testing and production of experimental vaccines andtreatments 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 SonyaHepinstall)
Glaxosmithkline (GSK)
