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A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body and evaluate the effect it has on herpes outbreaks
Details
| Lead sponsor | PowderMed |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2004-08 |
| Completion | 2005-07 |
Conditions
- HSV-2
Interventions
- pPJV7630 administered by PMED
Primary outcomes
- Adverse Events at all visits
- vaccine site evaluations
- laboratory parameters pre and post vaccination
Countries
United States