A highly anticipated test of an experimental Ebola vaccine will begin this week at the National Institutes of Health, amid mounting anxiety about the spread of the deadly virus in West Africa.
After an expedited review
by the U.S. Food and Drug Administration, researchers were given the
green light to begin what's called a human safety trial, said Dr.
Anthony Fauci, director of the National Institute of Allergy and
Infectious Diseases.
It will be the first test of this type of Ebola vaccine in humans.
The experimental vaccine,
developed by the pharmaceutical company GlaxoSmithKline and the NIAID,
will first be given to three healthy human volunteers to see if they
suffer any adverse effects. If deemed safe, it will then be given to
another small group of volunteers, aged 18 to 50, to see if it produces a
strong immune response to the virus. All will be monitored closely for
side effects.
The vaccine will be
administered to volunteers by an injection in the deltoid muscle of
their arm, first in a lower dose, then later in a higher dose after the
safety of the vaccine has been determined.
Some of the preclinical
studies that are normally done on these types of vaccines were waived by
the FDA during the expedited review, Fauci said, so "we want to take
extra special care that we go slowly with the dosing."
The vaccine did extremely
well in earlier trials with chimpanzees, Fauci said. He noted that the
method being used to prompt an immune response to Ebola cannot cause a
healthy individual to become infected with the virus.
Still, he said, "I have
been fooled enough in my many years of experience... you really can't
predict what you will see (in humans)."
According to the NIH, the
vaccine will also be tested on healthy volunteers in the United
Kingdom, Gambia and Mali, once details are finalized with health
officials in those countries.
No comments:
Post a Comment