A randomized, double blind, placebo-controlled, parallel group, pilot study to assess the safety and efficacy of a therapeutic Herpes Simplex Virus-2 (HSV-2) Deoxyribonucleic Acid (DNA) vaccine in HSV-2 positive adults
Phase 1
Completed
- Conditions
- Genital HerpesInfection - Sexually transmitted infections
- Registration Number
- ACTRN12615000094572
- Lead Sponsor
- Admedus Vaccines Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Genital HSV-2 seropositive and genital HSV-1 seronegative
Generally healthy
No birthmarks, tattoos, wounds or skin conditions on either forearm
Exclusion Criteria
Suffering acute or chronic disease
Pregant or nursing females
genital HSV-1, Hepatitis B or C, or HIV seropositive
Receiving medication known to have anti-HSV-2 activity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety. Possible adverse events include erythema, induration and pain at the injection site[The incidence and severity of adverse events in each treatment group, including vaccine related adverse events will be measured from enrollment until approximately 6 months after the booster injection. Possible adverse events include injection site reactions. The Principal Investigator will closely monitor these. There will also be a Data Safety Monitoring Review Committee that will meet regularly]
- Secondary Outcome Measures
Name Time Method Immunogenicity. Immune responses to HSV gD2 antigens will be measured using ELISA and ELISPOT assays[Antibody responses will be measured prior to vaccination and 4 weeks after each vaccination. Cell mediated responses will be measured at baseline and 1 week after each vaccination and at end of study visit 6 months post final vaccination]