Ebola Vaccine: First-Ever Human Trials For Experimental Drug To Begin Soon

An experimental Ebola vaccine developed by GlaxoSmithKline plc (NYSE:GSK) in collaboration with the National Institute of Allergy and Infectious Diseases, or NIAID, will be tested on human volunteers later this week, according to a statement published on the National Institutes of Health, or NIH, website.

The experimental vaccine will be administered to a small group of volunteers aged 18 to 50 at the NIH Clinical Center in Maryland where they will be closely monitored for adverse effects, the statement said. Considering the magnitude and severity of the current Ebola outbreak, which is the deadliest since the virus was discovered in 1976, pre-clinical tests that are normally performed before human trials were reportedly waived by the Food and Drug Administration, or FDA.

“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” NIAID Director Anthony Fauci said, in the statement. The results of the trial are expected by the end of the year, NIH said.

The vaccine uses a weakened strain of a type of chimpanzee cold virus called the chimp adenovirus type-3. This virus is used as a carrier to deliver benign genetic material derived from the Ebola virus species, making the recipient immune to infection from the virus, which has affected West African countries, the statement said.

“The experimental NIAID/GSK vaccine performed extremely well in protecting nonhuman primates from Ebola infection,” Fauci said, adding that the start of human trials is the “first step in a long process.”

GlaxoSmithKline said in a statement that funding from an international consortium formed to fight Ebola will “enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, so that if the trials are successful, stocks could then be made available immediately by GSK to the WHO to create an emergency immunization programme for high-risk communities.”

This will be the first time an Ebola vaccine is being tested on humans. Trials for another vaccine, developed by the Public Health Agency of Canada, are also scheduled to begin in the next few weeks.

More than 1,552 people have so far died from the current Ebola outbreak and over 3,000 have been infected. On Friday, Senegal reported its first confirmed case, making it the fifth West African country to be hit by the ongoing epidemic.