Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/1/2019 |
| Start Date: | December 2013 |
| End Date: | February 2016 |
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults
The purpose of this study is to test the safety and effectiveness of two experimental
therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3
doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a
minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within
the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive
therapy.
doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a
minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within
the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive
therapy.
Inclusion Criteria:
- HSV-2 seropositive
- A minimum of 1 year of reported history of genital herpes and either 2 to 9
recurrences within the year prior to screening or 2 to 9 recurrences per year prior to
starting suppressive therapy
Exclusion Criteria:
- History of receiving an investigational HSV vaccine
- Chronic illness for which a subject's immune system is suspected to be impaired or
altered, such as cancer, autoimmune conditions, or diabetes
- Pregnant or breastfeeding
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