A new candidate vaccine against hepatitis E, developed collaboratively by GlaxoSmithKline (GSK) and the Walter Reed Army Institute of Research (WRAIR), was found to be 95.5% effective in a Phase Two trial, according to a study to be published in the New England Journal of Medicine.
Hepatitis E, a waterborne strain of hepatitis that occurs almost exclusively in the developing world, is currently without cure or medical prophylaxis.
Three doses were administered over six months. After the third dose and over a follow-up period of approximately 20 months, there was a 7% attack rate in those in the placebo group and a 0.3% rate in those who had received the vaccine. The trial?s results also show that the vaccine was well-tolerated, with a safety profile similar to placebo, except for increased pain at the injection site; the most common adverse reaction besides injection site pain was mild to moderate headache after vaccination.
?This research represents a major breakthrough against hepatitis,? said Dr. Bruce Innis, a co-author of the study and Vice President, Clinical Research and Development, GSK Biologicals, the vaccine division of GSK. ?Hepatitis E is among the most common causes of jaundice in the developing world and its large, frequent outbreaks have devastating consequences. Today?s news that an effective vaccine may have been found means it?s time to put the disease on the global agenda and begin thinking about immunization strategies.?
?This project extends GSK?s long-standing commitment to hepatitis and builds upon our introduction of the world?s first recombinant hepatitis B vaccine as well as the first hepatitis A vaccine,? added W. Ripley Ballou, Vice President, Emerging Diseases, Clinical Research and Development, GSK Biologicals. ?This breakthrough reflects the hard work and expertise of our long-time collaborators in hepatitis research. We are actively working to identify new partners to complete the vaccine?s development.?
GSK will actively look to partner with the public sector to continue the vaccine?s development, in keeping with its tradition of public-private partnerships for vaccines addressing the diseases of the developing world, such as malaria, TB and HIV.