GlaxoSmithKline has announced an initial success on phase 1 trial of an Ebola vaccine.
The first results from the trial published on Thursday in the New England Journal of Medicine showed that a GSK and National Institute of Health Ebola candidate vaccine was well-tolerated and produced an immunological response in each of the 20 healthy adult volunteers in the United States who received it.
In a statement released on Thursday by the pharmaceutical company, the vaccine used in the trial conducted by the NIH was co-developed by the institute’s National Institute of Allergy and Infectious Diseases and Okairos, a biotechnology company acquired by GSK in 2013.
The statement read in part, “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.”
Commenting on the results, Chairman of Global Vaccines at GSK, 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. Over the coming weeks, we will see results from further phase 1 trials which will tell us 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.”
Slaoui added that the phase 3 trials would involve the vaccination of thousands of volunteers, including frontline health-care workers in affected countries, including Liberia and Sierra Leone, and possibly Guinea.
“If the candidate vaccine is able to protect these healthcare workers as we hope it will, it could significantly contribute to efforts to bring this epidemic under control,” he noted. Agency report