Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genocea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01667341
First received: August 14, 2012
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:

  1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)
  2. GEN-003: Antigens alone
  3. Placebo (DPBS diluent)

Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows:

  • 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
  • 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
  • 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
  • Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)

Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.


Condition Intervention Phase
Genital Herpes Simplex Type 2
Biological: GEN-003/M-2
Biological: GEN-003
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection

Resource links provided by NLM:


Further study details as provided by Genocea Biosciences, Inc.:

Primary Outcome Measures:
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 57 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
  • Change in proportion of days with detectable viral shedding [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose (10µg) GEN-003/M-2 Biological: GEN-003/M-2
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
Experimental: Mid Dose (30µg) GEN-003/M-2 Biological: GEN-003/M-2
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
Experimental: High Dose (100µg) GEN-003/M-2 Biological: GEN-003/M-2
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
Experimental: Low Dose (10µg), Antigen Only Biological: GEN-003
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
Experimental: Mid Dose (30µg), Antigen Only Biological: GEN-003
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
Experimental: High Dose (100µg), Antigen Only Biological: GEN-003
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
Placebo Comparator: Placebo Biological: Placebo
IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
Other Name: PBS, DPBS

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ages 18 to 50 years, inclusive.
  • Willing to practice a highly effective method of contraception that includes the use of a barrier method such as a condom.
  • Diagnosis of genital HSV-2 infection for > 1 year supported by ONE of the following documented in the medical history or performed at screening:

    • Western blot for HSV-2
    • Type-specific polymerase chain reaction (PCR) or viral culture
    • Compatible clinical history AND HSV-2 ELISA (HerpSelect) index value >3.5
  • A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation suppressive therapy.
  • Good general health status as determined by screening evaluation completed within 90 days prior to immunization. Any out of range screening clinical laboratory values should be considered not clinically significant by the Investigator.
  • Patient has provided written informed consent.
  • Ability and willingness to perform and comply with all study procedures including attending clinic visits as scheduled. Note: patients must provide, by the day of randomization, a minimum of 28 (equivalent of 14 days) baseline viral swab samples to continue to be eligible and be randomized).

Exclusion Criteria:

  • On suppressive antiviral medication within 7 days of baseline viral shedding evaluation.
  • Immunocompromised individuals, including those receiving systemic corticosteroids or other immunosuppressive agents.
  • Positive serologic test for HIV-1 infection; positive hepatitis B surface antigen (HBsAg) or antibody for hepatitis C (anti-HCV).
  • Active lesions consistent with herpetic disease at the time of scheduled immunization.
  • Pregnant or nursing women.
  • Receipt of any investigational drug within 30 days of the first scheduled day of immunization.
  • History of hypersensitivity to any component of the vaccine.
  • History of genital HSV-1 infection.
  • History of: (1) any form of ocular HSV infection, (2) HSV-related erythema multiforme, or (3) herpes meningitis or encephalitis.
  • Any other condition which in the opinion of the Investigator would interfere with the successful completion of the study protocol.
  • 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.
  • Prior immunization with a vaccine containing HSV-2 antigens.
  • Receipt of blood products within 90 days of the first immunization.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667341

Locations
United States, Alabama
University of Alabama Vaccine Research Unit
Birmingham, Alabama, United States, 35294-0006
United States, Indiana
Indiana University Infectious Disease Research
Indianapolis, Indiana, United States, 46202
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, Texas
Center for Clinical Studies - Houston
Houston, Texas, United States, 77030
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, United States, 77598
United States, Washington
UW Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Genocea Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Genocea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01667341     History of Changes
Other Study ID Numbers: GEN-003-001
Study First Received: August 14, 2012
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014