Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02571166 | HSV529 Vaccine in HSV-2 Seropositive Adults | PHASE1 | COMPLETED | 10 | — | — | Nov 1, 2015 | Dec 1, 2018 | Jan 14, 2019 | 1 | United States |
To determine the safety of HSV529 vaccine we will assess solicited Adverse Events, non-solicited Adverse Events and all Serious Adverse Events.
Change in density of total CD4+, CD4+ Foxp3+, and CD8+ T cells in the genital mucosa at sites of lesions prior to and post HSV529 vaccination
Change in the diversity and clonality of TCR composition pre and post vaccination
| Arm | Type | Description |
|---|---|---|
| HSV529 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| HSV529 | BIOLOGICAL | Live, Replication-defective HSV-2 virus |
| Valacyclovir | DRUG | 500 mg orally, once daily for 4 weeks |
Inclusion Criteria: 1. HSV-2 seropositive by UW Western blot with a history of recurrent genital herpes, with lesions in an area amenable to biopsy. 2. Aged 18 to 55 years on the day of enrollment. 3. In good general health with absence of significant health problems as determined by medical histor...