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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Dynavax Technologies Corporation
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT02117934
First received: April 15, 2014
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: HEPLISAV
Biological: Engerix-B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Proportion of subjects reporting clinically significant adverse events [ Time Frame: 12 months after last dose of HEPLISAV (Week 56) ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with type 2 diabetes mellitus with seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B [ Time Frame: Week 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8250
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HEPLISAV
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018 ISS) 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 Name: Hepatitis B vaccine (recombinant)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02117934

Contacts
Contact: Clinical Research Advantage, Inc. / Radiant Research 866-429-3707

  Show 40 Study Locations
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
Study Director: Robert Janssen, MD Dynavax Technologies Corporation
  More Information

No publications provided

Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT02117934     History of Changes
Other Study ID Numbers: DV2-HBV-23
Study First Received: April 15, 2014
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dynavax Technologies Corporation:
HBV vaccine
HEPLISAV-B
Hepatitis B vaccine
Hepatitis B
Hepatitis
Hepatitis B virus (HBV)
Prevention and Control
Healthy
Healthy volunteers

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human

ClinicalTrials.gov processed this record on August 28, 2014