Glaxo Smith Kline, in collaboration with the US National Institutes of Health, will begin phase I trials of their experimental Ebola vaccine
This week, human phase I safety trials will commence at the US National Institutes of Health to test GSK’s experimental Ebola vaccine.
The speed at which the vaccine has been approved to commence phase I trials is unprecedented, and comes as a result of an expedited review from the US FDA.
The trial will administer the vaccine to three healthy humans to assess the vaccines safety and observe and associated side effects. If the vaccine is considered to be safe, it will be administered to a small group of volunteers from the ages of eighteen to fifty. This trial will assess the efficacy of the vaccine and see if it produces a strong immune response. First, the vaccine will be administered at a low dose, and if it is deemed safe, it will be administered at a higher dose.
The vaccine has shown promise in preclinical trials on chimpanzees. Despite these encouraging results, Anthony Fauci, the director of the NIH, has said “I have been fooled enough in my many years of experience…you really can’t predict what you will see (in humans.)”
The NIH has said that the vaccine will also be tested outside of the United States, in the United Kingdom, Gambia and Mali.
Dr.Fauci has said that trials cannot take place in the countries affected by the outbreak, as they do not have the infrastructure in place to host these trials. The NIH was able to organise trials in the Gambia and Mali because of their previous collaborative ties with researchers there.
Even whilst the clinical trials are still taking place, GSK will receive funding from an international body set up to combat Ebola to manufacture 10,000 doses of the vaccine. These could be given to delivered to high risk locations in West Africa is the World Health Organisation allow it.
Whilst the GSK vaccine is slowly nearing possible approval, there are also other promising vaccine candidates, such as the NewLink Genetics vaccine, which will also move to human trials sometime this fall.
Read more about it here: Human trial of experimental Ebola vaccine begins this week