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.
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 (NIAID).
No comments:
Post a Comment