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Trial record 1 of 1 for:    NCT01667341
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Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine

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ClinicalTrials.gov Identifier: NCT01667341
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Genocea Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE August 14, 2012
First Posted Date  ICMJE August 17, 2012
Last Update Posted Date June 1, 2018
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date May 9, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 57 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens [ Time Frame: 33 weeks ]
  • Change in proportion of days with detectable viral shedding [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Genital Herpes Simplex Type 2
Intervention  ICMJE
  • Biological: GEN-003 with Matrix M-2
    IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
  • Biological: GEN-003
    IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
  • Biological: Placebo
    IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
    Other Names:
    • PBS
    • DPBS
Study Arms  ICMJE
  • Experimental: Low Dose GEN-003 with Matrix M-2
    10µg GEN-003, 50µg Matrix M-2 Adjuvant
    Intervention: Biological: GEN-003 with Matrix M-2
  • Experimental: Mid Dose GEN-003 with Matrix M-2
    30µg GEN-003, 50µg Matrix M-2 Adjuvant
    Intervention: Biological: GEN-003 with Matrix M-2
  • Experimental: High Dose GEN-003 with Matrix M-2
    100µg GEN-003, 50µg Matrix M-2 Adjuvant
    Intervention: Biological: GEN-003 with Matrix M-2
  • Experimental: Low Dose GEN-003 Only
    10µg GEN-003
    Intervention: Biological: GEN-003
  • Experimental: Mid Dose GEN-003 Only
    30µg GEN-003
    Intervention: Biological: GEN-003
  • Experimental: High Dose GEN-003 Only
    100µg GEN-003
    Intervention: Biological: GEN-003
  • Placebo Comparator: Placebo
    0.5 mL phosphate buffered saline
    Intervention: Biological: Placebo
Publications * Bernstein DI, Wald A, Warren T, Fife K, Tyring S, Lee P, Van Wagoner N, Magaret A, Flechtner JB, Tasker S, Chan J, Morris A, Hetherington S. Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial. J Infect Dis. 2017 Mar 15;215(6):856-864. doi: 10.1093/infdis/jix004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2014)
143
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2012)
150
Actual Study Completion Date  ICMJE May 9, 2014
Actual Primary Completion Date May 9, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01667341
Other Study ID Numbers  ICMJE GEN-003-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Genocea Biosciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Genocea Biosciences, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Genocea Biosciences, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP