Clinical trial NCT02910284: Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Herpes Simplex Type 2
Keywords: HSV
Herpes
Genital Herpes
Lead sponsor: Genocea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Up to 48 months post-dose
measure: Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (magnitude of HSV-2 viral shedding by PCR)
timeFrame: Up to 48 months post-dose
Secondary outcomes:
measure: Long-term effect of GEN-003 on HSV-lesion rate (percent of days with genital lesions present) during the swab collection periods
timeFrame: Up to 48 months post-dose
measure: Long-term immune responses to GEN-003 (Serum IgG levels assessed by ELISA)
timeFrame: Up to 48 months post-dose
measure: Long-term immune responses to GEN-003 (Serum HSV-2 neutralizing antibody levels assessed by a colorimetric neutralization assay)
timeFrame: Up to 48 months post-dose
measure: Long-term immune responses to GEN-003 (Spot-forming units (SFUs), fold rise, responder rate assessed by GrB ELISPOT)
timeFrame: Up to 48 months post-dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Chicago
country: United States
facility: University of Illinois - Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: NW Dermatology and Research
state: Oregon
city: Pittsburgh
country: United States
facility: Magee - Women's Hospital of UPMC
state: Pennsylvania
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: