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

Primary Purpose

Genital Herpes, HSV-2 Infection

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GEN-003
Matrix-M2
0.9% normal saline
Sponsored by
Genocea Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes focused on measuring HSV, Herpes, Genital Herpes, Vaccine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Birmingham
  • Medical Center for Clinical Research
  • Optimus Medical Group
  • UNC Health
  • Cincinnati Children's Hospital Medical Center
  • NW Dermatology and Research Clinic
  • Tekton Research
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GEN-003

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of Days With Genital Herpes Lesions
Subject-reported via electronic diary

Secondary Outcome Measures

Number of Genital Herpes Recurrences
Subject-reported via electronic diary
Number of Subjects Without Genital Herpes Recurrence
Subject-reported via electronic diary
Days Until First Genital Herpes Recurrence
Subject-reported via electronic diary
Duration of Genital Herpes Recurrences
Time in days per genital herpes recurrence

Full Information

First Posted
May 5, 2017
Last Updated
January 29, 2019
Sponsor
Genocea Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03146403
Brief Title
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
2017 business decision to cease GEN-003 spending.
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genocea Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes, HSV-2 Infection
Keywords
HSV, Herpes, Genital Herpes, Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GEN-003
Arm Type
Experimental
Arm Description
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
Intervention Type
Biological
Intervention Name(s)
GEN-003
Other Intervention Name(s)
HSV Therapeutic Vaccine
Intervention Description
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Intervention Type
Biological
Intervention Name(s)
Matrix-M2
Other Intervention Name(s)
Adjuvant
Intervention Description
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Intervention Type
Other
Intervention Name(s)
0.9% normal saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of Days With Genital Herpes Lesions
Description
Subject-reported via electronic diary
Time Frame
The 6-month period after vaccination
Secondary Outcome Measure Information:
Title
Number of Genital Herpes Recurrences
Description
Subject-reported via electronic diary
Time Frame
The 6-month period after vaccination
Title
Number of Subjects Without Genital Herpes Recurrence
Description
Subject-reported via electronic diary
Time Frame
6 months after vaccination
Title
Days Until First Genital Herpes Recurrence
Description
Subject-reported via electronic diary
Time Frame
The 6-month period after vaccination
Title
Duration of Genital Herpes Recurrences
Description
Time in days per genital herpes recurrence
Time Frame
The 6-month period after vaccination

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Optimus Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
UNC Health
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
NW Dermatology and Research Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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