26 Sep HSV Serial Biopsy Study
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.
This study involves a 48-week participation period. At the first visit, participants will be screened for HSV and HIV. After the Screening Visit, participants will be followed for up to 2 years until their next genital herpes outbreak. When they experience an outbreak, participants will be asked to come into the clinic as soon as the outbreak is noticed. A biopsy of the lesion site will occur, as well as a blood draw.
Additional blood draws and genital skin biopsies will be collected at the follow-up visits at week 2, 4, 8, 16, 32, and 48. No more than 6 biopsies will be collected during this study. There will be no at-home swab collection.
Participants will be compensated $775 if they complete the entire study. Parking and bus tickets are also provided.
Participant Eligibility
Eligibility Criteria:
▪ People 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):
▪ People of childbearing potential: pregnant or breastfeeding
▪ Immune suppression due to underlying illness, certain medications, or anti-cancer therapies
Contact
Virology Research Clinic
(206) 520-4340
Additional Study Details
Full Study Title
Serial Biopsy Study to Characterize Immunity to Genital Herpes
Investigator(s)
Christine Johnston, MD, MPH
Accepts Healthy Volunteers?
No
Study Site(s)
Virology Research Clinic
908 Jefferson St 11NJ-1166
Seattle, Washington 98104
