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Publish Date : 30-Aug-2014

Unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine. A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of an series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in West Africa.

Human trials of this candidate vaccine, being co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline, are to be accelerated with funding from an international consortium in response to the Ebola epidemic, which the World Health Organisation recently declared a public health emergency of international concern. A Ł2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID) will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, to start safety tests of the vaccine alongside similar trials in the US run by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).

The phase 1 trials will begin as soon as they receive ethical and regulatory approvals, which will be considered on an expedited basis. If approvals are 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 at the same time as the initial clinical trials, so that if the trials are successful stocks could then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities.

The candidate vaccine is against the Zaire species of Ebola, which is the one circulating in West Africa, and uses a single Ebola virus protein to generate an immune response. As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with Ebola. Pre-clinical research by the NIH and Okairos, a biotechnology company acquired last year by GSK, has indicated that it provides promising protection in non-human primates exposed to Ebola without significant adverse effects.

Safety trials with small groups of healthy volunteers are now required to ensure that the vaccine does not cause unforeseen side effects, and that it generates a good immune response to Ebola in humans, before it can be rolled out to larger at-risk populations, even on an experimental basis. To accelerate these trials, the NIH has generously agreed to provide the NIAID/GSK Ebola vaccine for safety studies led by the Oxford team, which will run in parallel to its own trials.

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