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

Phase 2

Terminated

• Conditions: Genital Herpes; HSV-2 Infection
• Interventions: Biological: GEN-003; Other: 0.9% normal saline; Biological: Matrix-M2

• Registration Number: NCT03146403
• Lead Sponsor: Genocea Biosciences, Inc.

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.

Study Timeline

• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Study Start: 2017-05-24
• Primary Completion: 2017-12-22
• Study Completion: 2018-06-11
• Results First Submitted: 2018-12-21
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Results First Posted: 2019-02-19
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEN-003	GEN-003	60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003	Matrix-M2	60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
Placebo	0.9% normal saline	0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

Primary Outcome Measures

Name	Time	Method
Percentage of Days With Genital Herpes Lesions	The 6-month period after vaccination	Subject-reported via electronic diary

Secondary Outcome Measures

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

Trial Locations

Locations (8)

UNC Health; 🇺🇸 Chapel Hill, North Carolina, United States

Tekton Research; 🇺🇸 Austin, Texas, United States

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Optimus Medical Group; 🇺🇸 San Francisco, California, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

NW Dermatology and Research Clinic; 🇺🇸 Portland, Oregon, United States

University of Washington; 🇺🇸 Seattle, Washington, United States