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

Genital Herpes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03146403
• Other study ID #: GEN-003-005
• Status: Terminated
• Phase: Phase 2
• Start date: May 24, 2017
• Est. completion date: June 11, 2018

Study information

• Verified date: January 2019
• Source: Genocea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: June 11, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Genital Herpes
• Herpes Genitalis
• Herpesviridae Infections
• HSV-2 Infection
• Infection

Intervention

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

Other:
• 0.9% normal saline
Placebo

Locations

Country	Name	City	State
United States	Tekton Research	Austin	Texas
United States	University of Alabama Birmingham	Birmingham	Alabama
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	Medical Center for Clinical Research	San Diego	California
United States	Optimus Medical Group	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Genocea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Days With Genital Herpes Lesions	Subject-reported via electronic diary	The 6-month period after vaccination
Secondary	Number of Genital Herpes Recurrences	Subject-reported via electronic diary	The 6-month period after vaccination
Secondary	Number of Subjects Without Genital Herpes Recurrence	Subject-reported via electronic diary	6 months after vaccination
Secondary	Days Until First Genital Herpes Recurrence	Subject-reported via electronic diary	The 6-month period after vaccination
Secondary	Duration of Genital Herpes Recurrences	Time in days per genital herpes recurrence	The 6-month period after vaccination