Today at 12:01 PM.
WASHINGTON – Federal researchers next week will start testing humans with an experimental vaccine to prevent the deadly Ebola virus.
The
National Institutes of Health announced Thursday that it is launching
the safety trial on a vaccine developed by the agency's National
Institute of Allergy and Infectious Diseases and GlaxoSmithKline.
Beginning Tuesday, it will test 20 healthy adult volunteers to see if
the virus is safe and triggers an adequate response in their immune
systems.
Even
though NIH has been testing other Ebola vaccines in people since 2003,
this is a first for this vaccine and its trial has been speeded up
because the outbreak in West Africa "is a public health emergency that
demands an all-hands-on-deck response," said Dr. Anthony Fauci, director
of the NIAID.
This
isn't a treatment for the disease, but a hoped-for preventative
measure. Fauci said the vaccine cannot cause Ebola in the volunteers
being tested.
He cautioned that there is no guarantee it will work: "I have been fooled enough in my many years of experience."
Fauci
doesn't expect results from this initial round of testing until the end
of the year, emphasizing that public health measures such as
quarantine, isolation, infection control and personal protective devices
are still the best way to fight the outbreak that so far has killed at
least 1,552 people in West Africa.
The
World Health Organization Thursday estimated that the death toll could
eventually exceed 20,000, while announcing new efforts to fight what
Fauci called the "rapidly evolving and currently uncontrolled outbreak."
The
major target of the vaccine, if it works, would be health care workers,
although residents of the area could also be eligible for the shots,
Fauci said. More than 240 health workers have become infected in this
outbreak, and more than 120 have died, he said.
If
it works, people would get one shot in the arm to protect them from an
immediate threat and eventually a second shot for longer-term immunity,
Fauci said.
Testing
will be at NIH's campus in Bethesda, Maryland, and involve a mixture
that uses both the current Zaire strain and another strain, Sudan. In
the second week of September, NIH and a British team will test that
vaccine on 100 volunteers in the United Kingdom; tests will commence in
Gambia and Mali in the middle of the month. American health officials
are also talking about a future trial in Nigeria.
Then
a different version of the vaccine, using only the Zaire strain, will
be tested on another 20 adults in October at NIH and elsewhere in the
United States.
Also
sometime in fall, Canadian and U.S. health officials will start safety
testing a different type of Ebola vaccine developed by NewLink Genetics
Corp. of Ames, Iowa.
The
U.S. vaccine takes a single protein from the Ebola virus and pairs it
with a chimpanzee cold virus to help as a delivery system. Past vaccines
have the used the same protein but different delivery systems.
Usually, the second stage of drug trials involve testing on larger numbers of people before it goes into final testing.
A
British consortium has pledged $4.6 million to help speed up the
vaccine tests. With some of that money, GlaxoSmithKline will be able to
begin manufacturing up to 10,000 doses of the U.S. vaccine, if the tests
are successful. The 10,000 doses will be ready by the end of the year
and if needed, production can be ramped up for stockpiling, GSK
spokeswoman Sarah Alspach said.
This
testing "is exactly what needs to be done," said Pardis Sabeti, a
Harvard University professor who has been studying Ebola and was in
Africa working the outbreak. http://www.foxnews.com/health/2014/08/28/us-to-begin-human-testing-ebola-vaccine-next-week/
