Simplirix Herpes Vaccine Description
Simplirix was a vaccine candidate intended to prevent genital herpes disease in women.
On September 29, 2010, GlaxoSmithKline (GSK) decided 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 preventing genital herpes disease was not met.
Simplirix Herpes Vaccine Clinical Trials
Clinical Trial NCT00224484: Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
The main goal of this Phase 3 study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).
Clinical Trial NCT00057330: HerpeVac Trial for Young Women
This Phase 3 study's primary purpose 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 to evaluate herpes if it is suspected.
Participants will be involved in study-related procedures for up to 20 months.