An “unprecedented international consortium” is fast-tracking GlaxoSmithKline’s investigational Ebola vaccine which could be given to healthy volunteers in the UK, the USA, the Gambia and Mali in the next few weeks.
The pace of human safety testing for the vaccine, co-developed with the US National Institutes of Health, has been speeded up in response to the Ebola virus outbreak in West Africa. GSK and NIH have partnered with a British-based consortium – the Wellcome Trust, the Medical Research Council and the UK Department for International Development – which has put in £2.8 million to fund safety tests at University of Oxford, alongside similar trials in the USA run by the National Institute of Allergy and Infectious Diseases (part of the NIH).
The Phase I trials will begin as soon as they receive ethical and regulatory approvals and if granted, the UK research teams could start vaccinating volunteers from mid-September. The consortium’s funding will also enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine, so that if the trials are successful stocks could then be made available immediately to the World Health Organisation to create an emergency immunisation programme in high-risk areas.
The Oxford study will involve 60 healthy volunteers, while those in the Gambia and Mali will each involve 40. Each set of volunteers will be split into groups of 20 who will receive different doses of the vaccine, which is based on an attenuated strain of chimpanzee cold virus.
GSK R&D chief Moncef Slaoui said the move “shows how private and public partners can pull together to respond to this critical public health emergency. Developing a new vaccine is complex with no guarantees of success and it’s still early days for our Ebola vaccine candidate…but we are encouraged by progress so far”.
The NIH will also collaborate with the US Department of Defense to support Phase I studies of NewLink Genetics Corp’s Ebola vaccine which has been developed by and licensed from the Public Health Agency of Canada.
