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 J&J said on Thursday that clinical trials of its new vaccine, which
includes technology from Danish biotech firm Bavarian Nordic BAVA.CO,
would commence in early 2015.
The move follows a decision to begin initial human testing of a
GlaxoSmithKline GSK.L vaccine this month and plans to test one
developed by Canadian government scientists, which has been licensed
to NewLink Genetics NLNK.O, in the autumn.
Human tests on the J&J vaccine were previously not expected to start
until late 2015 or early 2016.
J&J's long-term goal is to develop a vaccine that can protect
against both the Zaire and Sudan strains of Ebola, as well as a
related condition called Marburg disease. But the program has been
simplified in light of the current outbreak.
“Because of the emergency we decided to focus on the Ebola Zaire
strain, which is the one in the West Africa outbreak, and that’s why
we can accelerate the program significantly,” Chief Scientific
Officer Paul Stoffels told Reuters.
As with the GSK and NewLink programs, J&J is working on the clinical
trials with the U.S. National Institute of Allergy and Infectious
Diseases, part of National Institutes of Health.
“The crisis is so important here, and still expanding, that more
than one approach is warranted, in case the epidemic doesn’t come
under control in the coming months,” Stoffels said.
All of the initial Phase I trials will enroll healthy volunteers
with the goal of determining whether the experimental vaccines are
safe and whether they provoke a protective immune response.
Stoffels said it had not yet been decided where trials on the J&J
vaccine would be conducted or how many subjects would be involved.
The race to develop new drugs and vaccines has been spurred by a
World Health Organization ruling that it is ethical to use
experimental products in the current epidemic, given the high death
toll.
Governments and aid organizations have scrambled to contain the
disease, which according to the United Nations agency has killed
more than 1,900 in West Africa since March.
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J&J said its vaccine, which was developed by its Crucell unit in the
Netherlands, provided complete protection against the Zaire strain
of Ebola when tested on macaque monkeys.
Like a number of other experimental vaccines against various
diseases that are now in development, it uses a common cold virus,
called an adenovirus, to carry its payload. Immunization with the
J&J vaccine consists of two injections
one to prime the immune system and a second to boost the response.
They were given two months apart in the monkey tests. By contrast,
researchers are testing just a single shot of GSK's vaccine.
How safe and effective J&J's product will be in humans remains to be
seen, but more than 1,000 people have already received similar
experimental vaccines from Crucell in clinical trials for other
diseases with no apparent ill effects, offering some reassurance.
Bavarian Nordic, meanwhile, has used a similar approach in producing
a smallpox vaccine that has been stockpiled around the world and
tested on more than 7,300 people.
J&J is also stepping up research into potential drugs for Ebola by
undertaking an intensive review of known biological pathways used by
the virus to see if previously tested medicines might help.
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