GSK’s Ebola Vaccine Candidate Progresses
GlaxoSmithKline (GSK) reported on results from a small Phase I trial published in the New England Journal of Medicine that showed that an Ebola candidate vaccine from GSK and the US National Institutes of Health (NIH) was well-tolerated and produced an immunological response in each of the 20 healthy adult volunteers in the United States who received it.
The candidate vaccine used in the trial conducted by the NIH was co-developed by the NIH's National Institute of Allergy and Infectious Diseases 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.
Further data from ongoing Phase I trials in the US, the UK, Mali, and Switzerland are expected by the end of the year. If the trials are successful, the next phases of the clinical trial program will begin in early 2015 and will involve the vaccination of thousands of frontline healthcare workers in the two of the affected countries, Sierra Leone and Liberia. Further safety studies will also be conducted in west African countries not affected by the current outbreak in adults and children.
GSK says it continues to work with the World Health Organization (WHO), regulators, and other stakeholders to determine possible solutions to accelerate the development of the Ebola candidate vaccine with the goal of trying to limit the further spread of the epidemic. Its potential future use in mass vaccination campaigns will depend on whether WHO, regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made. GSK continues to actively explore with relevant organizations and partners ways 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.