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Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

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ClinicalTrials.gov Identifier: NCT02117934
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : January 10, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Tracking Information
First Submitted Date  ICMJE April 15, 2014
First Posted Date  ICMJE April 21, 2014
Results First Submitted Date  ICMJE December 8, 2017
Results First Posted Date  ICMJE January 10, 2018
Last Update Posted Date March 20, 2019
Study Start Date  ICMJE April 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
  • Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest [ Time Frame: Week 56 ]
    The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
  • Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response [ Time Frame: Week 28 ]
    Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
  • Proportion of subjects reporting clinically significant adverse events [ Time Frame: 12 months after last dose of HEPLISAV (Week 56) ]
  • Proportion of subjects with type 2 diabetes mellitus with seroprotective immune response (anti-HBs ≥ 10 mIU/mL) who receive HEPLISAV compared with subjects who receive Engerix-B [ Time Frame: Week 28 ]
Change History Complete list of historical versions of study NCT02117934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
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 the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
Official Title  ICMJE A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
Brief Summary The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: HEPLISAV
    Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
    Other Names:
    • Hepatitis B vaccine (recombinant), adjuvanted
    • HEPLISAV-B
  • Biological: Engerix-B
    Intramuscular injections at Week 0, Week 4, and Week 24
    Other Name: Hepatitis B vaccine (recombinant)
Study Arms  ICMJE
  • Experimental: HEPLISAV
    0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV.
    Intervention: Biological: HEPLISAV
  • Active Comparator: Engerix-B
    1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B.
    Intervention: Biological: Engerix-B
Publications *

*   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: February 26, 2016)
8374
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2014)
8250
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

A subject must meet all of the following criteria to be eligible for the trial:

Inclusion Criteria:

  • Be 18-70 years of age, inclusive
  • Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
  • If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.
  • Able and willing to provide informed consent

A subject with any one of the following criteria is not eligible for the trial:

Exclusion Criteria:

  • Previous receipt of any hepatitis B vaccine
  • History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV
  • History of autoimmune disorder
  • History of sensitivity to any component of study vaccines
  • Has received the following prior to the first injection:

    1. Within 28 days:

      • Any vaccine
      • Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
      • Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
      • Any other investigational medicinal agent
    2. Within 90 days: Blood products or immunoglobulin
    3. At any time: An injection of DNA plasmids or oligonucleotide
  • If female: Pregnant, nursing, or planning to become pregnant during the trial
  • Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin
  • Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02117934
Other Study ID Numbers  ICMJE DV2-HBV-23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dynavax Technologies Corporation
Study Sponsor  ICMJE Dynavax Technologies Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Janssen, MD Dynavax Technologies Corporation
PRS Account Dynavax Technologies Corporation
Verification Date March 2019

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