- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03146403
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama Birmingham
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California
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San Diego, California, United States, 92108
- Medical Center for Clinical Research
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San Francisco, California, United States, 94102
- Optimus Medical Group
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Health
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Oregon
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Portland, Oregon, United States, 97210
- NW Dermatology and Research Clinic
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Texas
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Austin, Texas, United States, 78745
- Tekton Research
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Washington
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Seattle, Washington, United States, 98104
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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 Names:
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
|
Placebo Comparator: Placebo
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
|
Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Days With Genital Herpes Lesions
Time Frame: The 6-month period after vaccination
|
Subject-reported via electronic diary
|
The 6-month period after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Genital Herpes Recurrences
Time Frame: The 6-month period after vaccination
|
Subject-reported via electronic diary
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The 6-month period after vaccination
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Number of Subjects Without Genital Herpes Recurrence
Time Frame: 6 months after vaccination
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Subject-reported via electronic diary
|
6 months after vaccination
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Days Until First Genital Herpes Recurrence
Time Frame: The 6-month period after vaccination
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Subject-reported via electronic diary
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The 6-month period after vaccination
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Duration of Genital Herpes Recurrences
Time Frame: The 6-month period after vaccination
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Time in days per genital herpes recurrence
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The 6-month period after vaccination
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Virus Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Disease Attributes
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Infections
- Communicable Diseases
- Herpes Simplex
- Herpesviridae Infections
- Herpes Genitalis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- GEN-003-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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