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Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01005407
Recruitment Status : Completed
First Posted : November 1, 2009
Results First Posted : January 11, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Study Description
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Brief Summary:
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Condition or disease Intervention/treatment Phase
Healthy Biological: HEPLISAV and/or Placebo Biological: Engerix-B Phase 3

Detailed Description:
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HEPLISAV and/or Placebo
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
 Biological: HEPLISAV and/or Placebo
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Other Name: Hepatitis B vaccine (recombinant), adjuvanted
Active Comparator: Engerix-B(1)
1.0 mL Engerix-B
 Biological: Engerix-B
Intramuscular (IM) injections on Week 0, Week 4 and Week 24
Other Name: Hepatitis B vaccine (recombinant)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects Who Have a Seroprotective Immune Response [ Time Frame: at Week 12 and at Week 32 ]
    Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®


Secondary Outcome Measures :
  1. Percentage of Participants With Local and Systemic Reaction to Injections [ Time Frame: within 7 days for post-injection reactions ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be 40 - 70 years of age, inclusive
  • be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)
  • be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
  • if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection

Exclusion Criteria:

  • if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
  • has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
  • has a known history of autoimmune disease
  • has previously received any hepatitis B vaccine (approved or investigational)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005407


Locations
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United States, Alabama
Huntsville, Alabama, United States
United States, California
San Diego, California, United States
Santa Ana, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Melbourne, Florida, United States
Pinellas Park, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Peoria, Illinois, United States
United States, Indiana
South Bend, Indiana, United States
United States, Maryland
Rockville, Maryland, United States
United States, Minnesota
Brooklyn Center, Minnesota, United States
Edina, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
United States, New York
Rochester, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Erie, Pennsylvania, United States
Grove City, Pennsylvania, United States
Jefferson Hills, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Upper Saint Clair, Pennsylvania, United States
United States, South Carolina
Anderson, South Carolina, United States
Greer, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Canada, Newfoundland and Labrador
Mount Pearl, Newfoundland and Labrador, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Dynavax Technologies Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT01005407    
Other Study ID Numbers: DV2-HBV-16
First Posted: November 1, 2009    Key Record Dates
Results First Posted: January 11, 2018
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dynavax Technologies Corporation:
HBV vaccine
Hepatitis B vaccine
Hepatitis B
Hepatitis
 HBV
Prevention & Control
Healthy
Healthy volunteers
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs