Hepatitis E, a waterborne strain of hepatitis that occurs almost exclusively in the developing world, is currently without cure or medical prophylaxis.
In the trial 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.
“This research represents a major breakthrough against hepatitis,” said Dr Bruce Innis, vice president, Clinical R&D, GSK Biologicals, the vaccine division of GSK.
“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.”
GSK sais it 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.
The vaccine technology was first developed by Genelabs Technologies, which sequenced the hepatitis E genome. Genelabs has granted an exclusive license to GlaxoSmithKline Biologicals for hepatitis E vaccines.