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

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

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.

Study Overview

• Status: Terminated
• Conditions: Genital Herpes; HSV-2 Infection
• Intervention / Treatment: Biological: GEN-003; Biological: Matrix-M2; Other: 0.9% normal saline

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Birmingham
  • California
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Health
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • NW Dermatology and Research Clinic
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Genocea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Vaccine; HSV; Genital Herpes; Herpes
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Infections; Communicable Diseases; Herpes Simplex; Herpesviridae Infections; Herpes Genitalis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GEN-003-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No