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The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCL-HB01, 1-mL dose | Experimental | VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses |
|
| Phosphate-buffered saline, 1-mL dose | Placebo Comparator | PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCL-HB01 | Biological | Investigational Product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion recurrences | Up to Day 450 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to Day 450 | |
| Time to first recurrence | Up to Day 450 | |
| Proportion of subjects recurrence-free |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mammen P Mammen, MD, FIDSA | Vical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Vaccine Research Clinic at University of Alabama at Birmingham | Birmingham | Alabama | 35294-2050 | United States | ||
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| Phosphate-buffered saline |
| Other |
Placebo |
|
|
| Up to Day 450 |
| Medical Center for Clinical Research |
| San Diego |
| California |
| 92108 |
| United States |
| QPS Broward Research | Hollywood | Florida | 33024 | United States |
| QPS Miami Research Associates | South Miami | Florida | 33143 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| Indiana University Infectious Disease Research | Indianapolis | Indiana | 46202 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| University of North Carolina (UNC) Institute of Global Health and Infectious Diseases | Chapel Hill | North Carolina | 27599 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| University of Utah School of Medicine - Division of Infectious Diseases | Salt Lake City | Utah | 84132 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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