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Trial record 1 of 1 for:    genocea 002b
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Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02910284
First Posted: September 22, 2016
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genocea Biosciences, Inc.
  Purpose
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.

Condition Intervention
Genital Herpes Simplex Type 2 Biological: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Genocea Biosciences, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Actual Study Start Date: September 16, 2016
Study Completion Date: July 14, 2017
Primary Completion Date: July 14, 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who received at least 1 dose of active GEN-003 and completed the GEN-003-002 study.
Criteria

Inclusion Criteria:

  1. Completion of Study GEN-003-002
  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:

  1. Any important protocol deviation in Study GEN-003-002.
  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910284


Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Illinois
University of Illinois - Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
The Fenway Institute
Boston, Massachusetts, United States, 02215
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
NW Dermatology and Research
Portland, Oregon, United States, 97210
United States, Pennsylvania
Magee - Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
Center for Clinical Studies
Houston, Texas, United States, 77004
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Genocea Biosciences, Inc.
  More Information

Responsible Party: Genocea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02910284     History of Changes
Other Study ID Numbers: GEN-003-002b
First Submitted: September 9, 2016
First Posted: September 22, 2016
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Genocea Biosciences, Inc.:
HSV
Herpes
Genital Herpes

Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female