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Pin to quick picksGlaxosmithkline Share News (GSK)

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UPDATE 2-Ebola vaccine trial halted temporarily after joint pains -Geneva hospital

Thu, 11th Dec 2014 16:33

* Merck-NewLink trial in Geneva halted after joint pains

* Lausanne says safety data "satisfactory" in GSK vaccinetrial (Adds statement on GSK Ebola vaccine, new paras 4-7)

By Stephanie Nebehay

GENEVA, Dec 11 (Reuters) - A clinical trial of an Ebolavaccine developed by Merck and NewLink has beenhalted temporarily as a precautionary measure after fourpatients complained of joint pains, the University of GenevaHospital said on Thursday.

"They are all fine and being monitored regularly by themedical team leading the study," it said in a statement.

The trials will resume on Jan. 5, on up to 15 volunteers,after checks to ensure that the joint pain symptoms in hands andfeet were "benign and temporary", the hospital said.

Fifty nine volunteers have been vaccinated so far in thehuman safety trials in Geneva, which began on Nov. 10.

Scientists are racing to develop Ebola vaccines after theworld's worst outbreak of the virus has killed more than 6,000people in West Africa so far this year.

Separately, safety data from a trial of a GlaxoSmithKline Ebola vaccine on 120 volunteers is "satisfactory", theUniversity of Lausanne Hospital said on Thursday.

The first results of the Lausanne hospital's trial of theGSK vaccine and whether it provides immunity against the virusare expected by the end of December, the university said in astatement.

"The safety data looked satisfactory so far," said ProfessorBlaise Genton, who is leading the GSK trial in Lausanne."General symptoms such as fever might be slightly more frequent,though no serious adverse event has been observed so far."

Scientists reported on Nov. 26 in the New England Journal ofMedicine that another version of the experimental GSK vaccinecaused no serious side effects and produced an immune responsein all 20 healthy volunteers who received it in an early-stagetrial.

The Geneva researchers reported on Dec. 2 that the firstpeople vaccinated with the Merck-NewLink shot had seen noserious side effects, but a few had mild fever.

On Thursday, the team said that four patients had reportedjoint pains in the second week that had lasted a few days.Before it was suspended, this first phase of the trial had beendue to continue for another week.

"The Geneva team has decided to allow time to understandwhat is happening. This precaution of momentarily suspending thetrial is usual and classic in all clinical trials," the teamsaid.

It was in close contact with researchers in the UnitedStates, Germany, Canada and Gabon who are carrying out the sametrial on the Merck-NewLink vaccine, it said. "These centres havenot observed symptoms of inflammation in their volunteers todate."

Marie-Paule Kieny, vaccine expert at the World HealthOrganisation, said that the delay to the Merck-NewLink trialwould allow time to see how widespread the problems are, but thetrial should then be able to continue as originally planned.

"It's not a setback, not at all," Kieny told a briefing.

GAVI, the global vaccines alliance, pledged $300 million onThursday to buy Ebola vaccines. (Additional reporting by Tom Miles; Editing by Susan Fenton)

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