Disappointing results from a Phase III trial conducted at 50 sites has scuttled GlaxoSmithKline's plans for a new genital herpes vaccine. The pharma giant tested Simplirix on more than 8,000 young women recruited in the U.S. and Canada, but discovered that only a fraction of the group was protected against the virus that triggers genital herpes.
"The estimate of vaccine effectiveness was 20 percent, but all estimates have statistical uncertainty, and this effect was not substantially different from zero," said the NIH in a statement.
The results were a surprise for investigators, who had been inspired to launch a big Phase III study in 2002 after the vaccine prevented herpes in some 70 percent of females in an earlier trial. Researchers said they were stumped by the failure, but planned to study the results more in an attempt to understand the data. GSK, meanwhile, says it will shutter the program.
- see the GSK release
- here's the Reuters story