Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity
NCT ID: NCT02910284
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
140 participants
OBSERVATIONAL
2016-09-16
2017-07-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Observational
Eligibility Criteria
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Inclusion Criteria
2. Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-002.
3. Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study GEN-003-002.
4. Willing and able to provide written informed consent.
5. Willing to perform and comply with all study procedures, including attending clinic visits as scheduled.
6. 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.
Exclusion Criteria
2. Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period 1.
3. Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period 1.
4. 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.
5. 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.
6. Presence or history of autoimmune disease, regardless of current treatment.
7. Receipt of a vaccine containing HSV-2 antigens other than GEN-003.
8. Pregnant women.
9. 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.
10. Onset of an AESI since Month 12 in study GEN-003-002.
11. 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.
18 Years
50 Years
ALL
No
Sponsors
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Genocea Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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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
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
Tekton Research
Austin, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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GEN-003-002b
Identifier Type: -
Identifier Source: org_study_id