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Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study

Primary Purpose

Genital Herpes Simplex Type 2

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GEN-003 Vaccine (30μg of each antigen)
GEN-003 Vaccine (60μg of each antigen)
Matrix-M2 Adjuvant (25μg)
Matrix-M2 Adjuvant (50μg)
Matrix-M2 Adjuvant (75μg)
Sponsored by
Genocea Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes Simplex Type 2 focused on measuring HSV, Herpes, genital infection, vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects who received placebo in GEN-003-002 and completed the study through Day 71 per protocol, including the collection of at least 45 anogenital swabs during Days 43 to 71.
  2. Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002.
  3. Willing and able to provide written informed consent.
  4. Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
  5. Men and women of childbearing potential, must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device (IUD), or barrier method (e.g., condom, diaphragm) for 28 days before and 90 days after receiving Study Drug.

Exclusion Criteria:

  1. On suppressive antiviral medication within 7 days prior to the first dose of Study Drug.
  2. Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002 study.
  3. History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
  4. Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
  5. Presence or history of autoimmune disease, regardless of current treatment.
  6. Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C infection (in the absence of a negative PCR result); positive hepatitis B surface antigen (HBsAg) within 6 months prior to the first dose of Study Drug.
  7. Clinically significant laboratory abnormality or a value ≥ Grade 2 within 56 days prior to the first dose of Study Drug.
  8. Receipt of blood products within 90 days prior to the first dose of Study Drug.
  9. Receipt of a live vaccine within 28 days prior to or a subunit vaccine within 14 days prior to the first dose of Study Drug or planned vaccination within 30 days following the last dose of Study Drug.
  10. Pregnant or nursing women.
  11. History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
  12. Other active, uncontrolled co-morbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.

NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to the first dose of Study Drug.

Sites / Locations

  • University of Alabama Vaccine Research Unit
  • Medical Center for Clinical Research
  • Quest Clinical Research
  • University of Illinois Department of Medicine
  • Indiana University Infectious Disease Research
  • The Fenway Institute
  • UNC Global HIV Prevention and Treatment Clinical Trials Unit
  • Cincinnati Children's Hospital Medical Center
  • Westover Heights Clinic
  • Magee-Womens Hospital of UPMC
  • Tekton Research
  • Center for Clinical Studies - Houston
  • Center for Clinical Studies
  • Center for Clinical Studies - Clear Lake/Webster
  • University of Utah
  • UW Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

GEN-003 Vaccine 30μg / Matrix-M 25μg

GEN-003 Vaccine 30μg / Matrix-M2 50μg

GEN-003 Vaccine 30μg / Matrix-M2 75μg

GEN-003 Vaccine 60μg / Matrix-M2 25μg

GEN-003 Vaccine 60μg / Matrix-M2 50μg

GEN-003 Vaccine 60μg / Matrix-M2 75μg

Arm Description

GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.

GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.

GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.

GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.

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

GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.

Outcomes

Primary Outcome Measures

Impact on clinical HSV-2 disease based on time to recurrence and lesion rate

Secondary Outcome Measures

Number of patients with adverse events as a measure of safety and tolerability

Full Information

First Posted
November 20, 2014
Last Updated
October 6, 2017
Sponsor
Genocea Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02300142
Brief Title
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
Official Title
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period Antiviral use. To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes Simplex Type 2
Keywords
HSV, Herpes, genital infection, vaccine

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GEN-003 Vaccine 30μg / Matrix-M 25μg
Arm Type
Experimental
Arm Description
GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
Arm Title
GEN-003 Vaccine 30μg / Matrix-M2 50μg
Arm Type
Experimental
Arm Description
GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.
Arm Title
GEN-003 Vaccine 30μg / Matrix-M2 75μg
Arm Type
Experimental
Arm Description
GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
Arm Title
GEN-003 Vaccine 60μg / Matrix-M2 25μg
Arm Type
Experimental
Arm Description
GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
Arm Title
GEN-003 Vaccine 60μg / Matrix-M2 50μg
Arm Type
Experimental
Arm Description
GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.
Arm Title
GEN-003 Vaccine 60μg / Matrix-M2 75μg
Arm Type
Experimental
Arm Description
GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
Intervention Type
Biological
Intervention Name(s)
GEN-003 Vaccine (30μg of each antigen)
Other Intervention Name(s)
HSV Vaccine
Intervention Description
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Intervention Type
Biological
Intervention Name(s)
GEN-003 Vaccine (60μg of each antigen)
Other Intervention Name(s)
HSV Vaccine
Intervention Description
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Intervention Type
Biological
Intervention Name(s)
Matrix-M2 Adjuvant (25μg)
Other Intervention Name(s)
MM2, Adjuvant
Intervention Description
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Intervention Type
Biological
Intervention Name(s)
Matrix-M2 Adjuvant (50μg)
Other Intervention Name(s)
MM2, Adjuvant
Intervention Description
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Intervention Type
Biological
Intervention Name(s)
Matrix-M2 Adjuvant (75μg)
Other Intervention Name(s)
MM2, Adjuvant
Intervention Description
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Primary Outcome Measure Information:
Title
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
Time Frame
53 weeks
Secondary Outcome Measure Information:
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
57 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who received placebo in GEN-003-002 and completed the study through Day 71 per protocol, including the collection of at least 45 anogenital swabs during Days 43 to 71. Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002. Willing and able to provide written informed consent. Willing to perform and comply with all study procedures including attending clinic visits as scheduled. Men and women of childbearing potential, must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device (IUD), or barrier method (e.g., condom, diaphragm) for 28 days before and 90 days after receiving Study Drug. Exclusion Criteria: On suppressive antiviral medication within 7 days prior to the first dose of Study Drug. Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002 study. History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis. Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents. Presence or history of autoimmune disease, regardless of current treatment. Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C infection (in the absence of a negative PCR result); positive hepatitis B surface antigen (HBsAg) within 6 months prior to the first dose of Study Drug. Clinically significant laboratory abnormality or a value ≥ Grade 2 within 56 days prior to the first dose of Study Drug. Receipt of blood products within 90 days prior to the first dose of Study Drug. Receipt of a live vaccine within 28 days prior to or a subunit vaccine within 14 days prior to the first dose of Study Drug or planned vaccination within 30 days following the last dose of Study Drug. Pregnant or nursing women. History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study. Other active, uncontrolled co-morbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements. NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to the first dose of Study Drug.
Facility Information:
Facility Name
University of Alabama Vaccine Research Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
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
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Illinois Department of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Infectious Disease Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Fenway Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UNC Global HIV Prevention and Treatment Clinical Trials Unit
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
45229-3039
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
98745
Country
United States
Facility Name
Center for Clinical Studies - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Center for Clinical Studies - Clear Lake/Webster
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
UW Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study

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