Lead Researcher:
Christine Johnston, MD, MPH

Study Title:
8‐week Serial Biopsy Study to Characterize Immunity to Genital Herpes

Study Description:
The purpose of this research study is to evaluate the skin cells that are infected with genital herpes and the immune system cells that are recruited to your skin when you have a genital herpes outbreak. Participants will be evaluated for study entry at a Screening Visit. This visit will involve a blood test for HSV and HIV. Eligible participants will then be followed for up to two years until their next HSV outbreak. At the time of an HSV outbreak, participants will come to the clinic for a genital biopsy at the site of the outbreak. Participants will be instructed in self‐collection of genital swabs and lesion site swabs and asked to return to the clinic every two weeks. Swabs will be collected once daily during the study period. Participants will have repeat genital biopsies at the lesion site at healing and 2, 4, and 8 weeks post-healing. Digital photographs of the lesion will be taken before and after each biopsy. Blood will be drawn at the outbreak visit and the final study visit.

Eligibility Criteria:

• Men and women 18 years of age or older
• HSV‐2 seropositive with a history of HSV outbreaks
• Willing to stop taking HSV suppressive therapy during the study period

Exclusions (conditions which would prevent a volunteer from participating in this study):

• HIV positive
• Women: pregnant or breastfeeding

Location:
University of Washington Virology Research Clinic
908 Jefferson St, 11 floor (Harborview Ninth & Jefferson Building)
Seattle, WA

Compensation:
Participants will receive up to $525 for completing the entire study.