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A Phase I Study Assessing Safety and Tolerability of a DNA Vaccine With a DNA Encoded Immunostimulator , Administered by Particle Mediated Epidermal Delivery Using the PowderMed ND10 Delivery System in HSV-2 Seronegative Healthy Volunteers
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.
Details
| Lead sponsor | PowderMed |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 42 |
| Start date | 2006-04 |
| Completion | 2006-12 |
Conditions
- HSV-2
Interventions
- pPJV7630 with pPJV2012 administered by PMED
Primary outcomes
- Safety, tolerability and reactogenicity of the investigational product as determined by AEs and evaluation of the site of vaccination at each visit.
Countries
United States