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

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 Overview

• Status: Completed
• Conditions: Genital Herpes Simplex Type 2
• Intervention / Treatment: Biological: Observational

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Genocea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2016
• Primary Completion (Actual): July 14, 2017
• Study Completion (Actual): July 14, 2017

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: HSV; Genital Herpes; Herpes
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis
• Other Study ID Numbers: GEN-003-002b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided