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

Dynavax Technologies Corporation

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Biological: Engerix-B

Biological: HEPLISAV and/or Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01005407

DV2-HBV-16

Details and patient eligibility

About

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

Full 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

Enrollment

2,452 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)