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Safety, Immunogenicity, Lot-to-lot Consistency Study of the 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: January 11, 2013
Last verified: January 2013
History of Changes
  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: Hepatitis B Vaccine (Recombinant), Adjuvanted
Biological: Hepatitis B vaccine (Recombinant)
 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:

U.S. FDA Resources

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 mlU/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 Biological: Hepatitis B Vaccine (Recombinant), Adjuvanted
Intramuscular (IM) injections on Day 0 and Week 4 plus a placebo (saline) injection at Week 24
Other Name: HEPLISAV™
Active Comparator: Engerix-B Biological: Hepatitis B vaccine (Recombinant)
Intramuscular (IM) injections on Day 0, Week 4, and Week 24
Other Name: Engerix-B®

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
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

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: January 11, 2013
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 May 21, 2013