GSK "encouraged" by Ebola vaccine results
27 Nov 2014
Phase 1 clinical trials of GlaxoSmithKline’s (GSK) Ebola vaccine was “well-tolerated” by the 20 volunteers who received it.
The GSK/ National Institutes of Health (NIH) vaccine uses a form of chimpanzee cold virus, known as chimpanzee adenovirus type 3, 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 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,” said Moncef Slaoui, chairman of Global Vaccines at GSK.
“We will know about that vaccine soon as over 200 people have now been immunised
Adrian Hill, UK Ebola vaccine investigator for GSK
GSK is also working on monovalent version of the vaccine that targets only the Zaire strain of Ebola.
“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,” said Slaoui.
Slaoui said that although initial results looked promising, data from today’s announcement is just the “first piece of the jigsaw” and that more information must now be gathered.
“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,” Slaoui said.
Adrian Hill, director of the Jenner Institute, and lead investigator of a UK safety trial of the GSK/NIH Ebola vaccine, said: “The immune responses reported suggest that the vaccine formulation to be used in West Africa should also be immunogenic.
“We will know about that vaccine soon as over 200 people have now been immunised. When we have these data in December it should be possible to decide on the most suitable dose to use and whether a booster dose will be needed in the West African efficacy trials”.
A spokesman for GSK confirmed that once further phase 1 trials had been successfully completed, the company could move towards a phase 2/3 study to consider efficacy.
“Only then, once these results are in, will regulators be able to consider if this vaccine candidate is safe and efficacious and governments will decide how it will be deployed,” the spokesman said.
Phase 3 clinical trials will, however, involve the vaccination of thousands of volunteers, including frontline healthcare workers in affected countries, including Liberia and Sierra Leone, and possibly Guinea, GSK confirmed.
A positive response to the announcement has been widespread, albeit marked with words of caution.
“We’ve been eagerly awaiting data from the first clinical trials of the Ebola virus vaccines and initial findings look promising,” said Jonathan Ball, professor of Molecular Virology at the University of Nottingham.
“Of course we don’t know if the immunity seen in vaccinated people is protective, nor if the other vaccines in development will perform better.”
