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

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ClinicalTrials.gov Identifier: NCT01005407
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : January 11, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

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 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


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)




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 ]


Information from the National Library of Medicine

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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)

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


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Sponsors and Collaborators
Dynavax Technologies Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT01005407     History of Changes
Other Study ID Numbers: DV2-HBV-16
First Posted: November 2, 2009    Key Record Dates
Results First Posted: January 11, 2018
Last Update Posted: February 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs