Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity
A Long-term Follow-up Study of Efficacy and Immunogenicity of GEN-003 in Subjects With Genital Herpes Simplex Virus Type 2 (HSV-2) Infection
1 other identifier
observational
140
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2016
CompletedStudy Start
First participant enrolled
September 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2017
CompletedOctober 20, 2017
October 1, 2017
10 months
September 9, 2016
October 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
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
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
Interventions
Eligibility Criteria
Subjects who received at least 1 dose of active GEN-003 and completed the GEN-003-002 study.
You may qualify if:
- Completion of Study GEN-003-002
- Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-002.
- Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study GEN-003-002.
- Willing and able to provide written informed consent.
- Willing to perform and comply with all study procedures, including attending clinic visits as scheduled.
- For each swab collection period, willing to not use HSV-2 antiviral therapy from 14 days before the swab collection period through the end of the period.
You may not qualify if:
- Any important protocol deviation in Study GEN-003-002.
- Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period 1.
- Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period 1.
- Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days before the beginning of Swab Collection Period 1.
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the Visit 1, any dose of corticosteroids within 30 days before Visit 1, or high-dose inhaled corticosteroids \[\>960 µg/day of beclomethasone diproprionate or equivalent\]) or other immunosuppressive agents.
- Presence or history of autoimmune disease, regardless of current treatment.
- Receipt of a vaccine containing HSV-2 antigens other than GEN-003.
- Pregnant women.
- History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
- Onset of an AESI since Month 12 in study GEN-003-002.
- Other active, uncontrolled comorbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Alabama - Birmingham
Birmingham, Alabama, 35294, United States
Medical Center for Clinical Research
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2016
First Posted
September 22, 2016
Study Start
September 16, 2016
Primary Completion
July 14, 2017
Study Completion
July 14, 2017
Last Updated
October 20, 2017
Record last verified: 2017-10