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). 5,960 female participants will be divided in 3 groups. One group was injected 3 times (at months 0, 1 and 6) with the herpes simplex vaccine, one group with the HavrixTM vaccine (control) and the other group with a Saline solution (placebo), respectively. Subjects were followed over 18 months.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Results

Vaccine published the results of this clinical trial on December 9, 2013.

Results: No statistically significant difference in the percentage of subjects with SAEs was observed between the HSV and saline group, or between the HSV and pooled control (HAV and saline) groups. The HSV vaccine was well tolerated, although a higher incidence of solicited local symptoms was observed in the HSV group than in the control group. Neither age nor HSV serostatus at the time of study entry had an impact on the safety profile of this vaccine. The HSV vaccine was immunogenic regardless of pre-vaccination HSV serostatus. Higher anti-gD geometric mean concentrations were observed in HSV-1 seropositive participants than in HSV-1 seronegative participants.

Conclusion: The HSV vaccine had an acceptable safety profile, and was well tolerated and immunogenic when administered to girls aged 10-17 years regardless of age or HSV pre-vaccination serostatus.