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GlaxoSmithKline reports positive Phase I trial results of Ebola vaccine candidate

GlaxoSmithKline (GSK) has reported positive results from a small Phase I trial of a vaccine candidate for the treatment of Ebola virus.

Ebola virus virion

The new vaccine candidate was co-developed by the National Institutes of Health’ (NIH) National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotechnology firm acquired by GSK in 2013.

The trial conducted by the NIH showed that the GSK/NIH Ebola vaccine candidate was well-tolerated and produced an immunological response in each of the 20 healthy adults in the US.

The vaccine uses a type of chimpanzee cold virus, known as chimpanzee adenovirus type 3 (ChAd3), which has been genetically designed to carry a non-infectious Ebola protein on its surface.

The bivalent vaccine is aimed at providing protection against two strains of the Ebola virus, Sudan and Zaire.

The parties have been jointly working to accelerate development of both this bivalent version of the candidate vaccine and a monovalent version targeting only the Zaire strain in response to the current Ebola epidemic.

Results from this Phase I trial have been published in the New England Journal of Medicine (NEJM) show.

GSK chairman of Global Vaccines Dr Moncef Slaoui said: "We are very encouraged by these positive first trial results showing this type of vaccine has an acceptable safety profile and can produce an immune response against Ebola in humans.

"Working with partners including the NIH, we’re doing all we can to advance development of a candidate vaccine in response to the Ebola crisis in west Africa.

"It’s important to remember that these data are the first piece in the jigsaw and we’re continuing to gather other important information."

Further data from the ongoing Phase I trials in the US, UK, Mali and Switzerland are expected to be reported by the end of 2014, which will provide more information about the profile of the monovalent vaccine.

According to the company, most significant results will come from a trial in Mali which is evaluating its safety and immune response in West African populations.

If these trials are successful, the next phases of the clinical trial program will be initiated in early 2015 to see whether the immune response seen in Phase I actually translates into providing people in affected countries with meaningful protection against Ebola.

The trials will involve the vaccination of thousands of frontline healthcare workers in the two of the affected countries Sierra Leone, Liberia and possibly Guinea.


Image: Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.