Issued: London, UK
Consortium includes GSK and research partners from University of Oxford, Centre Hospitalier Universitaire Vaudois in Lausanne and the Bernhard-Nocht Institute, and is backed by funding from the European Commission (EC)
A new European consortium has been formed including GSK and three leading research institutions to help further advance development of a candidate vaccine against Ebola, which is being co-developed by GSK and the US National Institutes of Health (NIH).
The consortium is backed by funding of €15.1 million from the European Commission Directorate General for Research and Innovation as part of its dedicated Horizon 2020 programme supporting research into treatments and vaccines for Ebola. The consortium also expects to receive an additional €1.4 million from the Swiss government.
The funding is already helping to implement an ongoing trial of an Ebola candidate vaccine being carried out in 120 healthy adult volunteers in Lausanne, Switzerland. If the safety and immunogenicity data from this and other ongoing phase 1 trials are encouraging, the EC funding will enable the consortium to begin larger phase 2 trials in Africa, which could start as early as January 2015.
These trials will evaluate the safety and ability of the GSK/NIH vaccine candidate to create an immune response against Ebola in adults and children, and will be carried out at established clinical study centers in West Africa, outside the most heavily-affected areas. It is anticipated that they will also investigate the effect of booster vaccination, if early stage booster trials underway at the University of Oxford are successful.
Dr Moncef Slaoui, Chairman of GSK Vaccines said: “We welcome the generous support from the European Commission and appreciate how quickly they have worked to secure the research grant for our work. These partnerships are essential to accelerate development of the vaccine candidate in response to the Ebola outbreak we are seeing in West Africa.”
Beyond this ‘EbolaVac’ project, GSK is working with the WHO, regulators and other stakeholders to prepare for efficacy trials in Ebola affected countries including Sierra Leone and Liberia, should the phase 1 trials be successful.
Further work continues to determine how and when near-term supplies of the Ebola candidate vaccine could be made available for targeted vaccination of additional health care workers and other people at high risk of infection in the affected countries, where the impact would be most likely to limit the further spread of the epidemic. Its future use in mass vaccination campaigns will depend on whether the vaccine candidate provides protection against Ebola without causing significant side- effects and how quickly large enough quantities can be made.
The vaccine consists of a single Ebola virus protein, which belongs to the Zaire strain circulating in West Africa, engineered in a chimpanzee adenovirus vector. As it does not contain infectious Ebola virus material, it cannot cause a person who is vaccinated to become infected with Ebola, but should generate immune responses aimed at protecting subjects when exposed to the Ebola virus.
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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ‘Risk factors’ in the company’s Annual Report on Form 20-F for 2013.