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

March 18, 2019 updated by: Dynavax Technologies Corporation

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

8374

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Clinical Research Advantage, Inc.
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Radiant Research
      • Chandler, Arizona, United States, 85224
        • Clinical Research Advantage, Inc.
      • Glendale, Arizona, United States, 85306
        • Clinical Research Advantage, Inc.
      • Mesa, Arizona, United States, 85213
        • Clinical Research Advantage, Inc.
      • Mesa, Arizona, United States, 85206
        • Clinical Research Advantage, Inc.
      • Phoenix, Arizona, United States, 85020
        • Clinical Research Advantage, Inc.
      • Phoenix, Arizona, United States, 85018
        • Clinical Research Advantage, Inc.
      • Phoenix, Arizona, United States, 85050
        • Clinical Research Advantage, Inc.
      • Scottsdale, Arizona, United States, 85251
        • Radiant Research
      • Tempe, Arizona, United States, 85283
        • Clinical Research Advantage, Inc.
      • Tucson, Arizona, United States, 85712
        • Radiant Research
      • Tucson, Arizona, United States, 85741
        • Clinical Research Advantage, Inc.
    • California
      • Santa Rosa, California, United States, 95405
        • Radiant Research
      • Vista, California, United States, 92083
        • Clinical Research Advantage, Inc.
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Clinical Research Advantage, Inc.
      • Colorado Springs, Colorado, United States, 80922
        • Clinical Research Advantage, Inc.
      • Denver, Colorado, United States, 80239
        • Radiant Research
    • Florida
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Radiant Research
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Radiant Research
    • Indiana
      • Evansville, Indiana, United States, 47725
        • Clinical Research Advantage, Inc
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Clinical Research Advantage, Inc.
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Radiant Research
    • Missouri
      • Saint Louis, Missouri, United States, 83141
        • Radiant Research
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Clinical Research Advantage, Inc.
      • Fremont, Nebraska, United States, 68025
        • Clinical Research Advantage, Inc.
      • Omaha, Nebraska, United States, 68124
        • Clinical Research Advantage, Inc.
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Clinical Research Advantage, Inc.
      • Las Vegas, Nevada, United States, 89128
        • Clinical Research Advantage, Inc.
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research
      • Cincinnati, Ohio, United States, 45249
        • Radiant Research
      • Columbus, Ohio, United States, 43212
        • Radiant Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research
      • Anderson, South Carolina, United States, 29621
        • Clinical Research Advantage, Inc.
      • Greer, South Carolina, United States, 29650
        • Radiant Research
    • Texas
      • Dallas, Texas, United States, 75231
        • Radiant Research
      • Plano, Texas, United States, 75093
        • Clinical Research Advantage, Inc.
      • San Antonio, Texas, United States, 78229
        • Radiant Research
    • Utah
      • Murray, Utah, United States, 84123
        • Radiant Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Other Names:
  • Hepatitis B vaccine (recombinant), adjuvanted
  • HEPLISAV-B
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.
Intramuscular injections at Week 0, Week 4, and Week 24
Other Names:
  • Hepatitis B vaccine (recombinant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 56
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
Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Robert Janssen, MD, Dynavax Technologies Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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