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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HEPLISAV
Engerix-B
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring HBV vaccine, HEPLISAV-B, Hepatitis B vaccine, Hepatitis B, Hepatitis, Hepatitis B virus (HBV), Prevention and Control, Healthy, Healthy volunteers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Clinical Research Advantage, Inc
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Radiant Research
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Clinical Research Advantage, Inc.
  • Radiant Research
  • Radiant Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HEPLISAV

Engerix-B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
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
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

Secondary Outcome Measures

Full Information

First Posted
April 15, 2014
Last Updated
March 18, 2019
Sponsor
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02117934
Brief Title
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
HBV vaccine, HEPLISAV-B, Hepatitis B vaccine, Hepatitis B, Hepatitis, Hepatitis B virus (HBV), Prevention and Control, Healthy, Healthy volunteers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEPLISAV
Arm Type
Experimental
Arm Description
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.
Arm Title
Engerix-B
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
HEPLISAV
Other Intervention Name(s)
Hepatitis B vaccine (recombinant), adjuvanted, HEPLISAV-B
Intervention Description
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Intervention Type
Biological
Intervention Name(s)
Engerix-B
Other Intervention Name(s)
Hepatitis B vaccine (recombinant)
Intervention Description
Intramuscular injections at Week 0, Week 4, and Week 24
Primary Outcome Measure Information:
Title
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
Description
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.
Time Frame
Week 56
Title
Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
Description
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
Time Frame
Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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 Within 90 days: Blood products or immunoglobulin 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Janssen, MD
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Advantage, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Radiant Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Radiant Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Radiant Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
Facility Name
Radiant Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Radiant Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Radiant Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Clinical Research Advantage, Inc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47725
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Radiant Research
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Radiant Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
83141
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Radiant Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31431412
Citation
Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.
Results Reference
derived
PubMed Identifier
29289383
Citation
Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.
Results Reference
derived

Learn more about this trial

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

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