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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCL-HB01, 0.25-mL dose | Experimental | VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses |
|
| PBS, 0.25-mL dose | Placebo Comparator | PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses |
|
| VCL-HB01, 0.5-mL dose | Experimental | VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses |
|
| PBS, 0.5-mL dose | Placebo Comparator | PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses |
|
| VCL-HB01, 1-mL dose | Experimental | VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses |
|
| VCL-HM01, 1-mL dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCL-HB01 | Biological | Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to Day 420 | |
| Viral shedding rate change from baseline | Baseline, Day 150 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Genital shedding rate change from baseline over time | Baseline, Day 330 | |
| Genital lesion rate change from baseline | Baseline, Day 330 | |
| Subclinical genital shedding rate change from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mammen P. Mammen, Jr., MD, FIDSA | Vical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Vaccine Research Clinic | Birmingham | Alabama | 35294 | United States | ||
| Broward Research Group |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
|
| PBS, 1-mL dose | Placebo Comparator | PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses |
|
| VCL-HM01 | Biological | Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin® |
|
| PBS | Biological | Phosphate-buffered saline |
|
| 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 |
| Baseline, Day 330 |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Indiana University Infectious Diseases Research | Indianapolis | Indiana | 46202 | United States |
| Westover Heights Clinic | Portland | Oregon | 97210 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| University of Utah - Division of Infectious Diseases | Salt Lake City | Utah | 84132 | United States |
| University of Washington Medical Center | Seattle | Washington | 98104 | United States |
| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |