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GSK Ebola vaccine to start safety studies

Will use volunteers in the US, UK and Africa
GSK GlaxoSmithKline house

GlaxoSmithKline is stepping up production of an experimental Ebola vaccine as human safety studies get underway at the US National Institute for Allergy and Infectious Disease (NIAID).

Testing in the US will start next week, while volunteers in Africa and the UK will start to receive the vaccine in the next couple of weeks, said the pharma company, just as the World Health Organization (WHO) warned that the current Ebola outbreak could eventually top 20,000 cases, 50 times larger than any previous case.

According to the most recent WHO figures more than 3,000 cases have been reported since the outbreak first took hold in West Africa in March, leading to 1,546 deaths. The countries affected are Guinea, Liberia, Nigeria, and Sierra Leone.

The UK studies of the vaccine - which is being developed alongside NIAID researchers - will be conducted by a team led by Professor Adrian Hill of the Jenner Institute at the University of Oxford.

The hope is that the first phase of testing could be completed by the end of the year and - if successful - the vaccine could then be deployed to help protect healthcare workers and other individuals at high risk of infection.

The WHO recently concluded that given the scale of the current Ebola outbreak it was ethically acceptable to use unproven medicines to tackle the disease, prompting Canada to donate up to 1,000 doses of another vaccine it had been testing in animals. Mapp Biopharmaceutical's Zmapp antibody has also been given to health workers and a missionary who contracted the virus in Africa.

The studies of GSK's vaccine will be funded to the tune of £2.8m ($4.65m) by an international consortium involving organisations such as WHO, the US National Institutes of Health (NIH), the Wellcome Trust, and the UK Medical Research Council (MRC) and the Department for International Development (DFID).

The money will also allow GSK to produce 10,000 additional doses of its vaccine which should be available for the start of the trials programme, said the company.

The candidate vaccine - acquired by GSK along with biotech outfit Okairos last year - is against the Zaire species of Ebola, the one currently circulating in west Africa, and uses a single Ebola virus protein to generate an immune response.

So far it has only been tested in non-human primates, but in these studies seems to have provided protection with no adverse effects.

The trials will start in the UK with around 60 patients and - if they go well - will then be extended to 40 people apiece in Gambia and Mali. In tandem, the NIAID will carry out tests of GSK's vaccine and the Canadian candidate - licensed to NewLink Genetics - that targets two Ebola species (Ebola Zaire and Ebola Sudan).

29th August 2014

From: Research, Healthcare



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