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Trial record 4 of 6 for:    gen-003

Evaluating New Formulation of Therapeutic HSV-2 Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02515175
First Posted: August 4, 2015
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genocea Biosciences, Inc.
  Purpose
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.

Condition Intervention Phase
Genital Herpes Simplex Type 2 Biological: Matrix-M2 Biological: GEN-003 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection

Resource links provided by NLM:


Further study details as provided by Genocea Biosciences, Inc.:

Primary Outcome Measures:
  • Change in HSV-2 viral shedding rate [ Time Frame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71) ]

Secondary Outcome Measures:
  • Immunogenicity measured by humoral (antibody) responses to vaccine antigens [ Time Frame: 13 weeks ]
  • Impact on clinical HSV-2 disease based on time to first recurrence [ Time Frame: 64 weeks ]
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 64 weeks ]
  • Reduction in HSV-2 viral shedding rate [ Time Frame: After vaccination (6 Months and 12 Months) ]
  • Impact on clinical HSV-2 disease based on lesion rate [ Time Frame: 64 weeks ]
  • Impact on clinical HSV-2 disease based on percent recurrence-free [ Time Frame: 64 weeks ]

Enrollment: 131
Study Start Date: November 2015
Study Completion Date: May 25, 2017
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GEN-003 60ug / Matrix-M2 50ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
Biological: Matrix-M2
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Name: Adjuvant
Biological: GEN-003
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Other Name: HSV Therapeutic Vaccine
Experimental: GEN-003 60ug / Matrix-M2 75ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
Biological: Matrix-M2
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Name: Adjuvant
Biological: GEN-003
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Other Name: HSV Therapeutic Vaccine
Placebo Comparator: Placebo
0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
Drug: Placebo
0.9% Normal Saline
Other Name: 0.9% Normal Saline

Detailed Description:

This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.

Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy
  • Diagnosis of genital HSV-2 infection for > 1 year
  • Willing and able to provide written informed consent
  • Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form
  • Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study
  • Men and women must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, tubal ligation, hysterectomy, licensed hormonal methods, intrauterine device, or barrier method (e.g., condom, diaphragm) with spermicide for 28 days before and 90 days after receiving the Study Drug

Exclusion Criteria

  • On suppressive antiviral therapy within 14 days of starting the study
  • Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study
  • Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days of starting the study
  • History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
  • Immunocompromised individuals
  • Use of corticosteroids within 30 days of starting the study and during the study or other immunosuppressive agents
  • Presence or history of autoimmune disease regardless of current treatment
  • Current infection with HIV or hepatitis B or C virus
  • History of hypersensitivity to any component of the vaccine
  • Prior receipt of GEN-003 or another vaccine containing HSV-2 antigens
  • Receipt of any investigational product within 30 days prior to Dose 1
  • Receipt of blood products within 90 days prior to Dose 1
  • Planned use of any vaccine over the course of the study
  • Pregnant or nursing women
  • History of drug or alcohol abuse
  • Other active, uncontrolled comorbidities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515175


Locations
United States, Alabama
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Massachusetts
The Fenway Institute
Boston, Massachusetts, United States, 02215
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Genocea Biosciences, Inc.
  More Information

Responsible Party: Genocea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02515175     History of Changes
Other Study ID Numbers: GEN-003-003
First Submitted: July 31, 2015
First Posted: August 4, 2015
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Genocea Biosciences, Inc.:
HSV
Herpes
Genital Herpes
Vaccine

Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs