NEJM STUDY SAYS VACCINE 95.5 PERCENT EFFECTIVE AGAINST HEPATITIS E

A new candidate vaccine against hepatitis E, developed by GlaxoSmithKline (GSK) and the Walter Reed Army Institute of Research, was found to be 95.5 percent effective in a Phase II trial, according to a study to be published in the New England Journal of Medicine (NEJM). 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 percent attack rate in those in the placebo group and a 0.3 percent 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.

Two thousand volunteers participated in the double-blind, placebo-controlled trial, conducted in accordance with international clinical guidelines and monitored by independent, international review boards.