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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.
Biological: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dynavax Technologies Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DV2-HBV-23

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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