Herpes vaccine prevents symptoms in HSV-1--, HSV-2--seronegative couples. (Two Phase III Trials).

NEW ORLEANS -- An investigational vaccine appears to provide significant protection against symptomatic genital herpes in select women, Dr. Kimberly Yeung-Yue said at the annual meeting of the American Academy of Dermatology.

The goal of two randomized, controlled, phase III trials was to assess the vaccine's efficacy in preventing genital herpes symptoms in the naive members of discordant couples, said Dr. Yeung-Yue, a clinical research fellow in dermatology at the University of Texas in Galveston. The vaccine included a herpes simplex virus type 2 glycoprotein D subunit and was formulated with an experimental adjuvant containing aluminum hydroxide plus monophosphoryl lipid A.

In the first study of 847 couples, the naive partner in each couple was both herpes simplex virus (HSV) type 1 and type 2 seronegative. In the second study of 2,491 couples, only 22% of couples involved a naive partner who was both HSV-1 and HSV-2 seronegative, she said.

Vaccinations of the naive partner occurred at baseline, 1 month, and 6 months; the couples were followed for 19 months.

In the first trial, more naive male and female partners in the placebo group developed symptoms of genital herpes, but the overall efficacy in preventing symptomatic genital herpes was only 25%-38%.

There was a striking difference in the vaccine's efficacy between the genders. In male naive partners, the vaccine had no efficacy, compared with placebo. In female naive partners, the vaccine had a 73% efficacy rate in preventing genital herpes symptoms, a statistically ...