Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity

Genital Herpes Simplex Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910284
• Other study ID #: GEN-003-002b
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: October 18, 2017
• Start date: September 16, 2016
• Est. completion date: July 14, 2017

Study information

• Verified date: October 2017
• Source: Genocea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genital Herpes Simplex Type 2
• Herpes Genitalis
• Herpes Simplex

Intervention

Biological:
• Observational

Locations

Country	Name	City	State
United States	Tekton Research	Austin	Texas
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	The Fenway Institute	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Illinois - Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Center for Clinical Studies	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Magee - Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	NW Dermatology and Research	Portland	Oregon
United States	Medical Center for Clinical Research	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Genocea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Long-term immune responses to GEN-003 (Serum IgG levels assessed by ELISA)		Up to 48 months post-dose
Secondary	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
Secondary	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