Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-20 @ 12:46 PM
Study NCT ID:
NCT02571166
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2015-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HSV529 Vaccine in HSV-2 Seropositive Adults
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Phase I Study of the Genital Immune Response to Live, Attenuated HSV529 Vaccine in HSV-2 Seropositive Adults
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 8377 | OTHER | Fred Hutch/UW Cancer Consortium IRB | View |