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

NCT03146403 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: GEN-003-005
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

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.

Conditions

Genital Herpes; HSV-2 Infection

Keywords

HSV; Herpes; Genital Herpes; Vaccine

Outcome Measures

Primary Outcomes (1)

• Percentage of Days With Genital Herpes Lesions

  Subject-reported via electronic diary

  The 6-month period after vaccination

Secondary Outcomes (4)

• Number of Genital Herpes Recurrences

  The 6-month period after vaccination

• Number of Subjects Without Genital Herpes Recurrence

  6 months after vaccination

• Days Until First Genital Herpes Recurrence

  The 6-month period after vaccination

• Duration of Genital Herpes Recurrences

  The 6-month period after vaccination

Study Arms (2)

GEN-003

EXPERIMENTAL

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

Biological: GEN-003; Biological: Matrix-M2

Placebo

PLACEBO COMPARATOR

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

Other: 0.9% normal saline

Interventions

GEN-003 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

Also known as: HSV Therapeutic Vaccine

GEN-003

Matrix-M2 BIOLOGICAL

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

Also known as: Adjuvant

GEN-003

0.9% normal saline OTHER

Placebo

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genocea Biosciences, Inc.: lead

Study Sites (8)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

UNC Health

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

NW Dermatology and Research Clinic

Portland, Oregon, 97210, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Herpes Genitalis; Herpes Simplex

Interventions

M2 protein, Influenza A virus; Adjuvants, Pharmaceutic; Saline Solution

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Crystalloid Solutions; Isotonic Solutions; Solutions

Limitations and Caveats

Small numbers of enrolled subjects likely led to a lack of statistical power. After a 2017 business decision to cease GEN-003 spending, the outcome measures were reduced to 6 months of follow up, rather than the originally planned 12 months.

Results Point of Contact

• Title: Jennifer LaVin
• Organization: Genocea

jennifer.lavin@genocea.com

617-876-8191

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 24, 2017
• Primary Completion: December 22, 2017
• Study Completion: June 11, 2018
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)