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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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02910284
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
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.
All locations for NCT02910284
United States (13)
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
Medical Center for Clinical Research
San Diego, California, United States, 92108
Quest Clinical Research
San Francisco, California, United States, 94115
University of Illinois - Chicago
Chicago, Illinois, United States, 60612
Indianapolis, Indiana, United States, 46202
The Fenway Institute
Boston, Massachusetts, United States, 02215
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
NW Dermatology and Research
Portland, Oregon, United States, 97210
Magee - Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Austin, Texas, United States, 78745
Center for Clinical Studies
Houston, Texas, United States, 77004
University of Washington
Seattle, Washington, United States, 98104
View full eligibility
Tris trial is registered with FDA with number: NCT02910284. The sponsor of the trial is Genocea Biosciences, Inc. and it is looking for 140 volunteers for the current phase.
Official trial title: 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
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