NCT01005407

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,452 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	HEPLISAV and/or Placebo	Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
BIOLOGICAL	Engerix-B	Intramuscular (IM) injections on Week 0, Week 4 and Week 24

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-01-01
• Completion: 2011-05-01
• First posted: 2009-11-02
• Last updated: 2019-03-20
• Results posted: 2018-01-11

Locations

32 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study