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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Biological: HEPLISAV and/or Placebo; Biological: Engerix-B

• Registration Number: NCT01005407
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Study Start: 2010-02
• Primary Completion: 2011-01
• Study Completion: 2011-05
• Disposition First Submitted: 2014-06-16
• Disposition First Submitted QC: 2014-06-16
• Disposition First Posted: 2014-06-19
• Results First Submitted: 2017-12-08
• Results First Submitted QC: 2017-12-08
• Results First Posted: 2018-01-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2452

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEPLISAV and/or Placebo	HEPLISAV and/or Placebo	0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)
Engerix-B(1)	Engerix-B	1.0 mL Engerix-B

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Have a Seroprotective Immune Response	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

Name	Time	Method
Percentage of Participants With Local and Systemic Reaction to Injections	within 7 days for post-injection reactions