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First GSK Ebola vaccine shipment due to arrive in Liberia

Fri, 23rd Jan 2015 06:00

By Kate Kelland

LONDON, Jan 23 (Reuters) - The first batch ofGlaxoSmithKline's experimental Ebola vaccine has beenshipped to West Africa and is expected to arrive in Liberialater on Friday, the British drugmaker said.

The shipment, of an initial 300 vials of the vaccine, willbe the first to arrive in one of the three main Ebola-affectedAfrican countries, GSK said in a statement.

It will be used in the first large-scale vaccine trials incoming weeks, in which healthcare workers helping to care forEbola patients will be among the first to get it.

Researchers hope eventually to enrol up to 30,000 people inthe trial, a third of whom would get GSK's candidate vaccine.

The vaccine, co-developed by the National Institutes ofHealth in the United States and Okairos, a biotechnology firmacquired by GSK in 2013, is currently being tested in five smallphase I safety trials in Britain, the United States, Switzerlandand Mali involving around 200 healthy volunteers in total.

"The initial phase I data ... are encouraging and give usconfidence to progress to the next phases of clinical testingwhich will involve the vaccination of thousands of volunteers,including frontline healthcare workers," said Moncef Slaoui,GSK's Global Vaccines chief.

The vaccine uses a type of chimpanzee cold virus to deliversafe genetic material from the Zaire strain of Ebola, the strainresponsible for the unprecedented West African epidemic.

Data so far show "an acceptable safety profile" including ina West African population and across a range of dose levels, GSKsaid, adding it had now selected the most appropriate dosage forthe Liberia trial.

The World Health Organization said on Thursday the Ebolaoutbreak in West Africa appears to be waning but cautionedagainst complacency in an epidemic that has seen 21,724 casesreported in nine countries since it started in Guinea a yearago. Some 8,641 people have died, according to WHO data.

Slaoui stressed that GSK's shot, like other candidates froma NewLink Genetics and Merck collaboration, andfrom Johnson & Johnson and Bavarian Nordic, isstill in development and can't be deployed unless and until itproves safe and effective.

"Any potential future use in mass vaccination campaigns willdepend on whether the WHO, regulators and other stakeholders aresatisfied ... and how quickly large quantities ... can be made,"he said. (Editing by James Dalgleish)

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