GSK Ebola vaccine shipped to Liberia

The shipment, expected to arrive later today, will be used to start the first large-scale efficacy trial of experimental Ebola vaccines in the coming weeks.

Initial data from five small Phase 1 clinical trials show that the candidate vaccine has an acceptable safety profile, including in a West African population, and across the different doses evaluated, GSK said.

“Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine

GSK global vaccines chairman Moncef Slaoui

Based on the safety and immunological data available from these trials, a selected dose will now be tested in a large Phase 3 clinical trial led by the US National Institutes of Health (NIH) which is expected to involve up to 30,000 people, one third of whom will receive GSK’s candidate Ebola vaccine.

This trial will begin in Liberia in the coming weeks, subject to regulatory approval, with further shipments of vaccines to follow.

Moncef Slaoui, chairman of Global Vaccines at GSK, said: “Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine. 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 healthcare 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 WHO (World Health Organisation), 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.”

Meanwhile, a spokesman for GSK told Laboratorytalk that the pharmaceutical firm is also hoping to work alongside the Centers for Disease Control (CDC) to conduct a clinical trial in Sierra Leone, but that trial is yet to be confirmed.

Several other Ebola vaccines are currently being trialled, including a two-part vaccine developed by US pharmaceutical firm Johnson & Johnson, and a vaccine candidate being co-developed by genetics firm NewLink and pharmaceutical giant Merck.

Both vaccines are currently in early phase clinical trials.

“Merck will work closely with [global health authorities] in efforts to expedite vaccine development and introduction,” Merck Vaccines chief public health and science officer Mark Feinberg told Laboratorytalk.com.

“This effort is characterised by new approaches to open communication and, where feasible and appropriate, collaboration between public and private sectors as well as within the private sector,” Feinberg said.