GlaxoSmithKline Part of International Consortium to Accelerate Ebola Vaccine Trials
Drug making giant GlaxoSmithKline (GSK) is joining forces with a number of internationally-recognised bodies including the UK Medical Research Council and US National Institutes of Health (NIH) to help push the testing of potential Ebola vaccines.
A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as this month, as part of a 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 NIH and GlaxoSmithKline, are to be accelerated with funding from an international consortium in response to the Ebola epidemic, which the World Health Organization recently declared a public health emergency of international concern.
A £2.8 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 USA 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.
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.
If the first volunteers vaccinated in the Oxford study show a good response with no adverse reactions, the trial will, after approval from the relevant authorities, be extended to volunteers at the MRC Unit in The Gambia.
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 that will receive different doses of the vaccine so researchers can evaluate the best dose to use in terms of both safety and activity.
NIAID is testing this same vaccine in the USA, in addition to a related vaccine that is designed to protect against two Ebola species (Ebola Zaire and Ebola Sudan).
Dr Moncef Slaoui, Chairman of Global R&D and Vaccines at GSK said: “This announcement 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 and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to the control of this or future Ebola outbreaks.”
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