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Evaluating New Formulation of Therapeutic HSV-2 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02515175
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Genocea Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 4, 2015
Last Update Posted Date May 22, 2018
Study Start Date  ICMJE November 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
Change in HSV-2 viral shedding rate [ Time Frame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • Immunogenicity measured by humoral (antibody) responses to vaccine antigens [ Time Frame: 13 weeks ]
  • Impact on clinical HSV-2 disease based on time to first recurrence [ Time Frame: 64 weeks ]
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 64 weeks ]
  • Reduction in HSV-2 viral shedding rate [ Time Frame: After vaccination (6 Months and 12 Months) ]
  • Impact on clinical HSV-2 disease based on lesion rate [ Time Frame: 64 weeks ]
  • Impact on clinical HSV-2 disease based on percent recurrence-free [ Time Frame: 64 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Immunogenicity measured by humoral (antibody) and T cell responses to vaccine antigens [ Time Frame: 13 weeks ]
  • Impact on clinical HSV-2 disease based on time to recurrence and lesion rate [ Time Frame: 64 weeks ]
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 64 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Official Title  ICMJE A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
Brief Summary This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Detailed Description

This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.

Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Genital Herpes Simplex Type 2
Intervention  ICMJE
  • Biological: Matrix-M2
    Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
    Other Name: Adjuvant
  • Biological: GEN-003
    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 Therapeutic Vaccine
  • Drug: Placebo
    0.9% Normal Saline
    Other Name: 0.9% Normal Saline
Study Arms  ICMJE
  • Experimental: GEN-003 60ug / Matrix-M2 50ug
    GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
    Interventions:
    • Biological: Matrix-M2
    • Biological: GEN-003
  • Experimental: GEN-003 60ug / Matrix-M2 75ug
    GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
    Interventions:
    • Biological: Matrix-M2
    • Biological: GEN-003
  • Placebo Comparator: Placebo
    0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
    Intervention: Drug: Placebo
Publications * Bernstein DI, Flechtner JB, McNeil LK, Heineman T, Oliphant T, Tasker S, Wald A, Hetherington S; Genocea study group. Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease. Vaccine. 2019 Jun 6;37(26):3443-3450. doi: 10.1016/j.vaccine.2019.05.009. Epub 2019 May 15.

*   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: August 9, 2016)
131
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
90
Actual Study Completion Date  ICMJE May 25, 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy
  • Diagnosis of genital HSV-2 infection for > 1 year
  • Willing and able to provide written informed consent
  • Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form
  • Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study
  • Men and women must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, tubal ligation, hysterectomy, licensed hormonal methods, intrauterine device, or barrier method (e.g., condom, diaphragm) with spermicide for 28 days before and 90 days after receiving the Study Drug

Exclusion Criteria

  • On suppressive antiviral therapy within 14 days of starting the study
  • Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study
  • Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days of starting the study
  • History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
  • Immunocompromised individuals
  • Use of corticosteroids within 30 days of starting the study and during the study or other immunosuppressive agents
  • Presence or history of autoimmune disease regardless of current treatment
  • Current infection with HIV or hepatitis B or C virus
  • History of hypersensitivity to any component of the vaccine
  • Prior receipt of GEN-003 or another vaccine containing HSV-2 antigens
  • Receipt of any investigational product within 30 days prior to Dose 1
  • Receipt of blood products within 90 days prior to Dose 1
  • Planned use of any vaccine over the course of the study
  • Pregnant or nursing women
  • History of drug or alcohol abuse
  • Other active, uncontrolled comorbidities
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 NCT02515175
Other Study ID Numbers  ICMJE GEN-003-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Genocea Biosciences, Inc.
Study Sponsor  ICMJE Genocea Biosciences, Inc.
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