NCT02571166

HSV529 Vaccine in HSV-2 Seropositive Adults

Phase I Study of the Genital Immune Response to Live, Attenuated HSV529 Vaccine in HSV-2 Seropositive Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety of HSV529 vaccine in healthy volunteers with HSV infection and to determine if administration of the HSV529 vaccine increases the immune response in genital skin.

Detailed description

The investigators will enroll a cohort of 8-10 HIV-1 seronegative, HSV-2 seropositive persons with recurrent genital HSV-2 lesions in an area amenable to genital biopsy. Participants will enroll when they have a genital lesion. They will undergo a lesion biopsy and a non-lesion biopsy. They will start suppressive valacyclovir 500 mg po daily for 4 weeks. Three days after completion of the 4 week valacyclovir course, participants will initiate vaccination with HSV529 on a 0, 1, and 6 month dose schedule. At each vaccination visits and at the 10 days post vaccination visits, genital biopsies will be performed. Genital biopsies will be performed at the site of genital lesion and at a non-lesional genital site. PBMC will also be drawn. Two days after the second vaccination, an optional biopsy will be offered. Overall, a minimum of 14 genital biopsies will be performed for each participant: 7 at the genital lesion site, and 7 at the genital non-lesion site. Four control biopsies from the upper arm will also be performed. For participants who undergo the optional biopsy two days after Dose 2, two additional genital biopsies will be performed. Participants will also collect daily genital swabs for HSV PCR for 30 days after each vaccination.

Conditions

• Herpes Simplex Virus 2

Interventions

Type	Name	Description
BIOLOGICAL	HSV529	Live, Replication-defective HSV-2 virus
DRUG	Valacyclovir	500 mg orally, once daily for 4 weeks

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-10-08
• Last updated: 2019-01-14

Locations

1 site across 1 country: United States