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J&J Ebola vaccine to start clinical trials in early 2015

Thu, 04th Sep 2014 04:00

* J&J working with Bavarian Nordic and U.S scientists

* Vaccine programme accelerated in light of current crisis

* Move follows plan to fast-track GSK and Canadian vaccines

By Ben Hirschler

Sept 4 (Reuters) - Scientists will fast-track tests onanother Ebola vaccine, this time from Johnson & Johnson,in another sign that the world's worst outbreak of the virus ismobilising research into the deadly disease.

J&J said on Thursday that clinical trials of its newvaccine, which includes technology from Danish biotech firmBavarian Nordic, would commence in early 2015.

The move follows a decision to begin initial human testingof a GlaxoSmithKline vaccine this month and plans totest one developed by Canadian government scientists, which hasbeen licensed to NewLink Genetics, in the autumn.

Human tests on the J&J vaccine were previously not expectedto start until late 2015 or early 2016.

J&J's long-term goal is to develop a vaccine that canprotect against both the Zaire and Sudan strains of Ebola, aswell as a related condition called Marburg disease. But theprogramme has been simplified in light of the current outbreak.

"Because of the emergency we decided to focus on the EbolaZaire strain, which is the one in the West Africa outbreak, andthat's why we can accelerate the programme significantly," ChiefScientific Officer Paul Stoffels told Reuters.

As with the GSK and NewLink programmes, J&J is working onthe clinical trials with the U.S. National Institute of Allergyand Infectious Diseases, part of National Institutes of Health.

"The crisis is so important here, and still expanding, thatmore than one approach is warranted, in case the epidemicdoesn't come under control in the coming months," Stoffels said.

All of the initial Phase I trials will enroll healthyvolunteers with the goal of determining whether the experimental vaccines are safe and whether they provoke aprotective immune response.

Stoffels said it had not yet been decided where trials onthe J&J vaccine would be conducted or how many subjects would beinvolved.

The race to develop new drugs and vaccines has been spurredby a World Health Organisation ruling that it is ethical to useexperimental products in the current epidemic, given the highdeath toll.

Governments and aid organisations have scrambled to containthe disease, which according to the United Nations agency haskilled more than 1,900 in West Africa since March.

J&J said its vaccine, which was developed by its Crucellunit in the Netherlands, provided complete protection againstthe Zaire strain of Ebola when tested on macaque monkeys.

Like a number of other experimental vaccines against variousdiseases that are now in development, it uses a common coldvirus, called an adenovirus, to carry its payload.

Immunisation with the J&J vaccine consists of two injections- one to prime the immune system and a second to boost theresponse. They were given two months apart in the monkey tests.By contrast, researchers are testing just a single shot of GSK'svaccine.

How safe and effective J&J's product will be in humansremains to be seen, but more than 1,000 people have alreadyreceived similar experimental vaccines from Crucell in clinicaltrials for other diseases with no apparent ill effects, offeringsome reassurance.

Bavarian Nordic, meanwhile, has used a similar approach inproducing a smallpox vaccine that has been stockpiled around theworld and tested on more than 7,300 people.

J&J is also stepping up research into potential drugs forEbola by undertaking an intensive review of known biologicalpathways used by the virus to see if previously tested medicinesmight help. (Reporting by Ben Hirschler; Editing by Sonya Hepinstall)

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