Simplirix was a vaccine candidate intended to prevent genital herpes disease in women.
On September 29, 2010 GlaxoSmithKline (GSK) made the decision NOT to pursue further worldwide development of Simplirix.
The decision was made following receipt of the results of the Herpevac Trial for Women.
The trial began in 2002 and 8,323 women ages 18-30 were vaccinated at 50 sites in the United States and Canada.
An assessment of the final trial results showed that the vaccine had an acceptable safety profile, but the primary trial endpoint, prevention of genital herpes disease, was not met.
Clinical Trial NCT00057330: HerpeVac Trial for Young Women
- The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected.
- The study will enroll approximately 7550 healthy women.
- These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group).
- Participants will receive their assigned vaccine at 0, 1, and 6 months.
- Participants will have 9 scheduled study visits and additional unscheduled visits for evaluation of herpes if it is suspected.
- Participants will be involved in study-related procedures for up to 20 months.