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

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ClinicalTrials.gov Identifier: NCT02300142
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Genocea Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Genital Herpes Simplex Type 2 Biological: GEN-003 Vaccine (30μg of each antigen) Biological: GEN-003 Vaccine (60μg of each antigen) Biological: Matrix-M2 Adjuvant (25μg) Biological: Matrix-M2 Adjuvant (50μg) Biological: Matrix-M2 Adjuvant (75μg) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GEN-003 Vaccine 30μg / Matrix-M 25μg
GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
Biological: GEN-003 Vaccine (30μg of each antigen)
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 Vaccine

Biological: Matrix-M2 Adjuvant (25μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • MM2
  • Adjuvant

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

Biological: Matrix-M2 Adjuvant (50μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • MM2
  • Adjuvant

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

Biological: Matrix-M2 Adjuvant (75μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • MM2
  • Adjuvant

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

Biological: Matrix-M2 Adjuvant (25μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • MM2
  • Adjuvant

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

Biological: Matrix-M2 Adjuvant (50μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • MM2
  • Adjuvant

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

Biological: Matrix-M2 Adjuvant (75μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • MM2
  • Adjuvant




Primary Outcome Measures :
  1. Impact on clinical HSV-2 disease based on time to recurrence and lesion rate [ Time Frame: 53 weeks ]

Secondary Outcome Measures :
  1. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 57 weeks ]


Information from the National Library of Medicine

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

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.


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): NCT02300142


Locations
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United States, Alabama
University of Alabama Vaccine Research Unit
Birmingham, Alabama, United States, 35294-0006
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, Illinois
University of Illinois Department of Medicine
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Infectious Disease Research
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
The Fenway Institute
Boston, Massachusetts, United States, 02215
United States, North Carolina
UNC Global HIV Prevention and Treatment Clinical Trials Unit
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Tekton Research
Austin, Texas, United States, 98745
Center for Clinical Studies - Houston
Houston, Texas, United States, 77030
Center for Clinical Studies
Houston, Texas, United States, 77065
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, United States, 77598
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
UW Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Genocea Biosciences, Inc.

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Responsible Party: Genocea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02300142     History of Changes
Other Study ID Numbers: GEN-003-002a
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by Genocea Biosciences, Inc.:
HSV
Herpes
genital infection
vaccine

Additional relevant MeSH terms:
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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