GSK shipped the first batch of its candidate Ebola vaccine to Liberia, the company said Friday.
The shipment includes 300 vials of GSK’s candidate vaccine that uses biotechnology to collect a chimpanzee cold virus called adenovirus type 3 (ChAd3) to deliver the genetic material of the Zaire strain of Ebola to test subjects.
The vaccine will be the first to arrive in one of the countries most affected by Ebola. The vaccine will be part of the first large-scale phase III trial for a candidate Ebola vaccine.
Researchers in Liberia will administer the vaccine to approximately 30,000 people as part of the phase III trial, which will determine the large-scale efficiency of the Ebola vaccine.
One third of the 30,000 subjects will receive the candidate vaccine. Data gathered from this phase III clinical trial will determine whether the vaccine provides any significant protection.
Meanwhile, the candidate vaccine is currently undergoing five small phase I clinical trials. Test subjects, located at trial sites in Mali, the U.S., the UK and Switzerland, include approximately 200 healthy individuals.
Researchers will use the immunological and safety data from these tests to determine the proper level of doses before continuing to the next clinical testing phase.
GSK will be starting a large phase II safety trial in West African countries that have not been affected by Ebola.
GSK and other professional health organizations have plans to conduct trials in other countries most affected by Ebola, including Guinea and Sierra Leone.
"Shipping the vaccine ... is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine,” GSK Chairman of Global Vaccines Moncef Slaoui said. “The initial phase I data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing which will involve the vaccination of thousands of volunteers, including frontline health care workers. If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks.
"It is important to remember that this vaccine is still in development and any potential future use in mass vaccination campaigns will depend on whether World Health Organization, regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made."