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This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (percent of anogenital swabs positive for HSV-2 DNA by PCR) | Up to 48 months post-dose | |
| Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (magnitude of HSV-2 viral shedding by PCR) | Up to 48 months post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term effect of GEN-003 on HSV-lesion rate (percent of days with genital lesions present) during the swab collection periods | Up to 48 months post-dose | |
| Long-term immune responses to GEN-003 (Serum IgG levels assessed by ELISA) | Up to 48 months post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received at least 1 dose of active GEN-003 and completed the GEN-003-002 study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Medical Center for Clinical Research |
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| Long-term immune responses to GEN-003 (Serum HSV-2 neutralizing antibody levels assessed by a colorimetric neutralization assay) | Up to 48 months post-dose |
| Long-term immune responses to GEN-003 (Spot-forming units (SFUs), fold rise, responder rate assessed by GrB ELISPOT) | Up to 48 months post-dose |
| San Diego |
| California |
| 92108 |
| United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| University of Illinois - Chicago | Chicago | Illinois | 60612 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| The Fenway Institute | Boston | Massachusetts | 02215 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| NW Dermatology and Research | Portland | Oregon | 97210 | United States |
| Magee - Women's Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable 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 |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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