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There are two identified types of herpes simplex viruses (HSV-1 and HSV-2) with HSV-2 causing most cases of genital herpes, but HSV-1 is increasingly becoming more prevalent.1 HSV-1 was found to be the most common cause of genital herpes in young heterosexual2 women and college students while affecting all socioeconomic classes.3,4 Furthermore, many infections are asymptomatic and transmission is possible while asymptomatic due to viral shedding.5 Additionally, complications can occur from genital herpes infections including lesions, both genital and non-genital, meningitis and neonatal infections transmitted from infected mothers during birth. Treatment for genital herpes is aimed at relieving symptoms and shortening the course of the outbreak, however there is currently no cure or vaccine for prevention.6 A prophylactic vaccine may help to decrease the prevalence of genital herpes for both HSV-1 and HSV-2 disease and infection. 

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Belshe and colleagues conducted a multicentered, randomized, double-blind, Phase III efficacy trial in women who were seronegative for HSV-1 and HSV-2 to evaluate the efficacy of a HSV-2 glycoprotein D-based subunit vaccine (gD-2) to prevent genital herpes caused by HSV-1, HSV-2 or both from month 2 (1 month after vaccine dose 2) through month 20. Prevention of HSV-1 or HSV-2 after doses two and three as well as prevention of genital herpes caused by specific HSV types were secondary end points. Women ages 18 to 30 years, lacking in serious health problems, willing to use effective birth control methods 1 month prior through 2 months after the final vaccination, and not currently pregnant were included. Patients were randomly assigned in a 1:1 ratio to receive either the HSV vaccine 0.5mL or inactivated hepatitis A (control) vaccine 0.5mL, given intramuscularly at 0, 1, and 6 months. Serum specimens to monitor for asymptomatic infection were obtained at 0, 2, 6, 7, 12, 16, and 20 months. Questionnaires were administered at baseline and at each serologic assessment to assess sexual–risk behavior.7

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There were 8323 women who were vaccinated with 56% being 18-22 years of age and 80% of participants were white. The HSV vaccine was not found to be efficacious with only 20% protection against genital disease overall. Three doses of the vaccine exhibited 77% efficacy against HSV-1, but no efficacy against HSV-2. HSV-1 was the more common cause of genital herpes disease in the control group with 21 cases caused by HSV-1 compared to 14 cases caused by HSV-2. There was an increased risk of HSV-1 infection associated with having ≥ 6 lifetime sexual partners, > 1 partner in the previous year, and being 18-22 years of age. An increased risk of HSV-2 infection was seen in women having ≥ 6 lifetime sexual partners, ≥ 6 partners in the past 12 months, currently or ever having a partner with herpes, a history of any sexually transmitted infection, nonwhite race, and being a U.S. resident. The most common adverse event reported with the HSV vaccine compared to the control vaccine was swelling at the injection-site (odds ratio ...

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