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.
Study Type
OBSERVATIONAL
Enrollment
140
University of Alabama - Birmingham
Birmingham, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
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)
Time frame: 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)
Time frame: Up to 48 months post-dose
Long-term effect of GEN-003 on HSV-lesion rate (percent of days with genital lesions present) during the swab collection periods
Time frame: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Serum IgG levels assessed by ELISA)
Time frame: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Serum HSV-2 neutralizing antibody levels assessed by a colorimetric neutralization assay)
Time frame: 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)
Time frame: Up to 48 months post-dose
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University of Illinois - Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
The Fenway Institute
Boston, Massachusetts, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
NW Dermatology and Research
Portland, Oregon, United States
Magee - Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
...and 3 more locations