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Trial record 59 of 126 for:    HSV-2

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

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. Identifier: NCT03146403
Recruitment Status : Terminated (2017 business decision to cease GEN-003 spending.)
First Posted : May 9, 2017
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Information provided by (Responsible Party):
Genocea Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Genital Herpes HSV-2 Infection Biological: GEN-003 Biological: Matrix-M2 Other: 0.9% normal saline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : June 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

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 Name: HSV Therapeutic Vaccine

Biological: Matrix-M2
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Name: Adjuvant

Placebo Comparator: Placebo
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
Other: 0.9% normal saline

Primary Outcome Measures :
  1. Percentage of Days With Genital Herpes Lesions [ Time Frame: The 6-month period after vaccination ]
    Subject-reported via electronic diary

Secondary Outcome Measures :
  1. Number of Genital Herpes Recurrences [ Time Frame: The 6-month period after vaccination ]
    Subject-reported via electronic diary

  2. Number of Subjects Without Genital Herpes Recurrence [ Time Frame: 6 months after vaccination ]
    Subject-reported via electronic diary

  3. Days Until First Genital Herpes Recurrence [ Time Frame: The 6-month period after vaccination ]
    Subject-reported via electronic diary

  4. Duration of Genital Herpes Recurrences [ Time Frame: The 6-month period after vaccination ]
    Time in days per genital herpes recurrence

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03146403

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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
Optimus Medical Group
San Francisco, California, United States, 94102
United States, North Carolina
UNC Health
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
NW Dermatology and Research Clinic
Portland, Oregon, United States, 97210
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.
  Study Documents (Full-Text)

Documents provided by Genocea Biosciences, Inc.:
Study Protocol  [PDF] October 13, 2017
Statistical Analysis Plan  [PDF] February 7, 2018

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Responsible Party: Genocea Biosciences, Inc. Identifier: NCT03146403     History of Changes
Other Study ID Numbers: GEN-003-005
First Posted: May 9, 2017    Key Record Dates
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genocea Biosciences, Inc.:
Genital Herpes
Additional relevant MeSH terms:
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Communicable Diseases
Herpesviridae Infections
Herpes Genitalis
DNA Virus Infections
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Immunologic Factors
Physiological Effects of Drugs