First results of GSK/NIH Ebola vaccine are published
The next phases of the clinical trial programme will start early next year
GSK's Ebola vaccine produced immunological responses from the 20 healthy adults participating in a small Phase 1 trial.
The participants in the clinical trial in Maryland, US, found that the GSK/NIH Ebola candidate vaccine was well-tolerated and there were no serious side effects.
The results have been published in the New England Journal of Medicine.
The vaccine candidate used in the trial was co-developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotechnology company acquired by GSK in 2013. It uses a type of chimpanzee cold virus, known as chimpanzee adenovirus type 3 (ChAd3), as a carrier to deliver genetic material from two strains of the Ebola virus – the Sudan strain and the Zaire strain, which is responsible for the current Ebola outbreak in West Africa.
GSK has been working with the NIH 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.
'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,' said Dr Moncef Slaoui, Chairman of Global Vaccines at GSK, who stressed that 'these data are the first piece in the jigsaw and we’re continuing to gather other important information'.
Over the coming weeks, GSK will see results from further Phase 1 trials which will tell the company more about the profile of the monovalent vaccine; most significantly results from a trial in Mali which is assessing its safety and immune response in West African populations.
'If the combined data from these trials are positive, the next phases of the clinical trial programme will begin in early 2015 to see whether the immune response we are seeing in Phase 1 actually translates into providing people in affected countries with meaningful protection against Ebola,' said Slaoui.
GSK said it would continue to explore with relevant organisations and partners all opportunities to accelerate the development of manufacturing at an industrial scale.
Additionally, the company is looking at whether use of a booster vaccine may help provide longer-lasting protection.
