|
 The initiation of the Phase I study in Britain, which had been
expected about now, marks further progress in the race to develop a
vaccine against a disease that has killed more than 8,000 people in
West Africa since last year.
Two other experimental vaccines, one from GlaxoSmithKline and a
rival from NewLink and Merck, are already in clinical development.
However, the J&J vaccine offers a different approach, since it
involves two separate injections.
U.S.-based J&J said on Tuesday it had produced enough vaccine to
treat more than 400,000 people, which could be used in large-scale
clinical trials by April 2015, and a total of 2 million courses
would be available through the course of 2015. Previously, J&J
expected more than 1 million courses this year.
It also now predicts it can make enough vaccine for 5 million
treatments, if required, over a 12- to 18-month period.
Just how much Ebola vaccine will be needed depends on how quickly
the epidemic in Liberia, Sierra Leone and Guinea is brought under
control and declines. Currently, experts project demand at anywhere
between 100,000 and 12 million doses.
"As long as there are still Ebola patients, there is the risk that
it will continue to go around the region," Paul Stoffels, J&J’s
chief scientific officer, told reporters.
The initial stage of first-in-human testing with J&J's vaccine is
being conducted by experts at the University of Oxford, where 72
healthy volunteers will get different regimens combining the vaccine
components or placebo.
Additional clinical studies are planned in the United States later
this month and soon after in Africa, where volunteers will receive
the vaccine in Kenya, Uganda and Tanzania.
[to top of second column] |
In all, some 300 subjects will be involved in Phase I testing, after
which J&J hopes to move rapidly into larger studies, with
final-stage Phase III trials planned for the second quarter of 2015.
The J&J and Bavarian vaccine uses a so-called "prime-boost" approach
of giving a first shot to stimulate the immune system, followed by a
second booster a few weeks later.
The GSK and NewLink vaccines have been tested initially as single
shots, although there is growing debate as to whether two-stage
vaccination might be a more strategic option, since it is likely to
provide better protection. The downside is that it would make mass
immunization more complicated.
"What we are doing with prime-boost is going for maximal protection,
as well as long-term protection," Stoffels said.
Importantly, tests have shown the J&J vaccine can be stored in a
normal fridge for several months, rather than needing special
freezing, which is difficult in rural Africa.
(Editing by Louise Heavens)
[© 2014 Thomson Reuters. All rights
reserved.] Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
