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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01005407
First received: October 29, 2009
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Proportion 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® [ Time Frame: at Week 12 and at Week 32 ] [ Designated as safety issue: No ]
  • Lot-to-lot consistency as measured by geometric mean consistency (GMC), measured at 4 weeks after the last active dose of HEPLISAV™ [ Time Frame: at Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall incidence of post-injection reactions and adverse events in each treatment group. Seroprotection rate and geometric mean concentration (GMC) as determined by anti-HBsAg antibody titers for HEPLISAV-treated subjects vs. Engerix-B-treated subjects. [ Time Frame: measured at timepoints up to Week 52 ] [ Designated as safety issue: Yes ]

Enrollment: 2452
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Four lots of HEPLISAV
0.5 mL HEPLISAV
Biological: HEPLISAV
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
1.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injections on Week 0, Week 4, and Week 24
Other Name: Hepatitis B vaccine (recombinant)

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
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: NCT01005407

  Show 32 Study Locations
Sponsors and Collaborators
Dynavax Technologies Corporation
  More Information

No publications provided by Dynavax Technologies Corporation

Additional 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
Study First Received: October 29, 2009
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Dynavax Technologies Corporation:
HBV vaccine
Hepatitis B vaccine
Hepatitis B
Hepatitis
HBV
Prevention & Control
Healthy
Healthy volunteers

ClinicalTrials.gov processed this record on November 20, 2014