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

NCT ID: NCT03146403

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-24
• Study Completion Date: 2018-06-11

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.

Conditions

Genital Herpes; HSV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GEN-003

60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection

Group Type: EXPERIMENTAL

GEN-003

Intervention Type: BIOLOGICAL

HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D

Matrix-M2

Intervention Type: BIOLOGICAL

Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

Placebo

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

Group Type: PLACEBO_COMPARATOR

0.9% normal saline

Intervention Type: OTHER

Placebo

Interventions

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

Intervention Type: BIOLOGICAL

Matrix-M2

Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

Intervention Type: BIOLOGICAL

0.9% normal saline

Placebo

Intervention Type: OTHER

Other Intervention Names

HSV Therapeutic Vaccine; Adjuvant

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genocea Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

UNC Health

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

NW Dermatology and Research Clinic

Portland, Oregon, United States

Tekton Research

Austin, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GEN-003-005

Identifier Type: -

Identifier Source: org_study_id