Clinical trial NCT03146403: Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
Official title: A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Genital Herpes
HSV-2 Infection
Keywords: HSV
Herpes
Genital Herpes
Vaccine
Lead sponsor: Genocea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.

Detailed description: This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial. Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the maintenance dose) of GEN-003 or placebo.

Subjects will use a daily electronic reporting tool for reporting the presence or absence of genital herpes lesions, and severity of genital herpes symptoms.

GEN-003-005 was originally designed to follow subjects for 12 months after the maintenance dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in 3Q2017 to cease GEN-003 spending and activities.

Eligibility criteria: Inclusion Criteria:

* Completed Study GEN-003-003
* Received all 3 GEN-003 doses (any dose combination) in Study GEN-003-003
* Received last dose of GEN-003 within 11 to 18 months prior
* Reported data in the daily electronic reporting period on at least 80% of days in Study GEN-003-003
* Collected at least 45 swabs (of 56 total expected swabs) during the Month 11 to 12 swab collection period in Study GEN-003-003
* Willing and able to provide written informed consent
* Willing to perform and comply with all study procedures
* Postmenopausal or willing to practice a highly effective method of contraception for 28 days before and 90 days after enrollment

Exclusion Criteria:

* Did not meet all eligibility criteria in Study GEN-003-003, or received incorrect treatment in Study GEN-003-003
* Use of suppressive antiviral medication within 14 days prior
* Use of topical steroids or antiviral medication in the anogenital region within 14 days prior
* Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV recurrence frequency or intensity within 14 days prior
* History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
* Immunocompromised individuals
* Diagnosis or suspicion of an AESI
* Diagnosis or suspicion of any other autoimmune disease not listed in Appendix 4 of the protocol
* Vaccine-related SAE in GEN-003-003
* Known current infection with HIV or hepatitis B or C virus
* History of hypersensitivity to any component of the vaccine
* Prior receipt of another vaccine containing HSV-2 antigens other than GEN-003
* Receipt of any IP within 30 days prior to the maintenance dose of GEN-003/placebo
* Receipt of any blood product within 90 days prior to the maintenance dose
* Receipt of a live vaccine within 28 days prior to or any other vaccine within 14 days prior to maintenance dose
* Planned use of any vaccine from the maintenance dose to 28 days after the maintenance dose
* Pregnant or nursing women
* History of drug or alcohol abuse
* Other active, uncontrolled comorbidities
* Changes to medication used to manage an underlying comorbidity within 60 days prior

Primary outcomes:
measure: Percentage of Days With Genital Herpes Lesions
timeFrame: The 6-month period after vaccination
Secondary outcomes:
measure: Number of Genital Herpes Recurrences
timeFrame: The 6-month period after vaccination
measure: Number of Subjects Without Genital Herpes Recurrence
timeFrame: 6 months after vaccination
measure: Days Until First Genital Herpes Recurrence
timeFrame: The 6-month period after vaccination
measure: Duration of Genital Herpes Recurrences
timeFrame: The 6-month period after vaccination
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: Optimus Medical Group
state: California
city: Chapel Hill
country: United States
facility: UNC Health
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 Clinic
state: Oregon
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: