Human Test of the Ebola Vaccine to begin this week

The human trial of an experimental Ebolavaccine will begin this week, according to the National Institutes of Health, United States of America.

In a statement on Tuesday, the Director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, said the US Food and Drug Administration had given the researchers at the institute the approval to begin the human safety trial.

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 between 18 and 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 told the AFP on Tuesday.

He noted that the method being used to prompt an immune response to Ebola could not 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 finalised with health officials in those country.

Meanwhile, officials from the Centres for Disease Control and Prevention, US, have said that the human trials of Ebola vaccines cannot currently be done in the four countries affected by the recent outbreak – Guinea, Sierra Leone, Liberia and Nigeria due to the conditions of existing health care infrastructure in these countries.

Fauci said Gambia and Mali were selected because the NIH had “long-standing collaborative relationships” with researchers in those countries.

He, however, said that the agency was in talks with health officials in Nigeria about conducting part of the safety trial there.

He added that funds generated from an international consortium formed to fight Ebola would enable GlaxoSmithKline to begin manufacturing up to 10,000 additional doses of the vaccine while clinical trials were ongoing.

Fauci added that the experimental drug would be made available to the World Health Organisation, should it decides to use it for emergency immunsation in high-risk communities.

The GSK/NIAID vaccine is one of the two leading candidate vaccines. The other was developed by the Public Health Agency of Canada and licensed this month to NewLink Genetics, a company based in Iowa.

According to the NIH and the CDC, safety trials of that vaccine will start this fall, according to the AFP.

Source: Punch