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GSK Ebola vaccine trial seen moving to wider phase in February

Fri, 19th Dec 2014 11:30

GENEVA, Dec 19 (Reuters) - Trials of GlaxoSmithKline's experimental Ebola vaccine are likely to move to asecond phase in February, later than previously suggested, aftera meeting of national regulators said they needed moreinformation.

The World Health Organization, which hosted a meeting ofnational regulatory authorities and ethics committees earlierthis week, said they had thoroughly discussed all aspects of theproposed trials at the two-day meeting.

"Reviewing countries requested additional documentation fromthe manufacturer of the vaccine, GlaxoSmithKline, beforeauthorization of the trials," the WHO said in a statement.

Countries where the trials are planned -- Cameroon, Ghana,Mali, Nigeria and Senegal -- should receive and review theadditional information by the end of January.

"If these steps are completed to the satisfaction of thenational authorities, Phase II trials are likely to begin inFebruary," the statement said.

The GSK vaccine is already undergoing Phase I trials, tocheck its safety in humans, in Switzerland, Britain, Mali andthe United States, and is one of the two leading candidatevaccines for Ebola already undergoing tests.

The other vaccine, from NewLink Genetics is alsostill in Phase I trials. One of its trials, in Geneva, wassuspended earlier this month after some patients complained ofjoint pains.

Johnson & Johnson plans to start clinical trialswith a third vaccine shortly.

WHO officials have said they hope the unprecedentedfast-track trials mean vaccines may be widely available aroundthe middle of 2015, although they also hope the outbreak will beover by then. So far it has killed almost 7,000 people.

There are still many unresolved questions about the use ofexperimental vaccines, including whether subjects will need oneor two injections. (Reporting by Tom Miles; editing by Ben Hirschler and MarkTrevelyan)

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