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

Genocea Biosciences, Inc.13 sites in 1 country140 target enrollmentSeptember 16, 2016

ConditionsGenital Herpes Simplex Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Genital Herpes Simplex Type 2
Sponsor: Genocea Biosciences, Inc.
Enrollment: 140
Locations: 13
Primary Endpoint: Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (magnitude of HSV-2 viral shedding by PCR)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 16, 2016

End Date

July 14, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Genocea Biosciences, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Completion of Study GEN-003-002
•Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-
•Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study GEN-003-
•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.

Exclusion Criteria

•Any important protocol deviation in Study GEN-003-
•Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period
•Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period
•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
•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-
•Pregnant women.
•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-

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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 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 (Spot-forming units (SFUs), fold rise, responder rate assessed by GrB ELISPOT)(Up to 48 months post-dose)