Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Genital Herpes Simplex Type 2

Intervention / Treatment
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* Biological: VCL-HB01
* Biological: VCL-HM01
* Biological: PBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VCL-HB01, 0.25-mL dose<br>VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses | Biological: VCL-HB01<br>* Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®<br>|
| Placebo Comparator: PBS, 0.25-mL dose<br>PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses | Biological: PBS<br>* Phosphate-buffered saline<br>|
| Experimental: VCL-HB01, 0.5-mL dose<br>VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses | Biological: VCL-HB01<br>* Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®<br>|
| Placebo Comparator: PBS, 0.5-mL dose<br>PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses | Biological: PBS<br>* Phosphate-buffered saline<br>|
| Experimental: VCL-HB01, 1-mL dose<br>VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses | Biological: VCL-HB01<br>* Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®<br>|
| Experimental: VCL-HM01, 1-mL dose<br>VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses | Biological: VCL-HM01<br>* Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®<br>|
| Placebo Comparator: PBS, 1-mL dose<br>PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses | Biological: PBS<br>* Phosphate-buffered saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to Day 420 | 
| Viral shedding rate change from baseline |  | Baseline, Day 150 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genital lesion rate change from baseline |  | Baseline, Day 150 | 
| HSV DNA copy numbers change from baseline |  | Baseline, Day 150 | 
| Genital recurrence rate compared with placebo |  | Up to Day 330 | 
| Subclinical genital shedding rate change from baseline |  | Up to Day 150 | 
| T-cell and/or antibody responses change from baseline |  | Baseline, Days 7, 35, 63, 150, 330 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes Simplex Virus, Type 2, Herpes, HSV-2