Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Genital Herpes, HSV-2 Infection

Intervention / Treatment
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* Biological: GEN-003
* Biological: Matrix-M2
* Other: 0.9% normal saline


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEN-003<br>60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection | Biological: GEN-003<br>* HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D<br>* Other names: HSV Therapeutic Vaccine;Biological: Matrix-M2<br>* Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.<br>* Other names: Adjuvant;|
| Placebo Comparator: Placebo<br>0.9% normal saline administered as a 0.5mL intramuscular (IM) injection | Other: 0.9% normal saline<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Days With Genital Herpes Lesions | Subject-reported via electronic diary | The 6-month period after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Genital Herpes Recurrences | Subject-reported via electronic diary | The 6-month period after vaccination | 
| Number of Subjects Without Genital Herpes Recurrence | Subject-reported via electronic diary | 6 months after vaccination | 
| Days Until First Genital Herpes Recurrence | Subject-reported via electronic diary | The 6-month period after vaccination | 
| Duration of Genital Herpes Recurrences | Time in days per genital herpes recurrence | The 6-month period after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes, HSV, Genital Herpes, Vaccine