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Completed

NCT Number: NCT01005407

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

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

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Key information

Conditions

Healthy Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mount Pearl, Newfoundland and Labrador, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HEPLISAV and/or Placebo

Biological

Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24

Other names: Hepatitis B vaccine (recombinant), adjuvanted

Engerix-B

Biological

Intramuscular (IM) injections on Week 0, Week 4 and Week 24

Other names: Hepatitis B vaccine (recombinant)

Primary outcomes

  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 outcomes

  1. Percentage of Participants With Local and Systemic Reaction to Injections

    Time frame: within 7 days for post-injection reactions

Sponsors and collaborators

Lead sponsor

Dynavax Technologies Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2009
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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