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

Completed · Phase 3 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01005407

Run by

Dynavax Technologies Corporation

People needed

2452

Starts

2010-02-01

Expected to finish

2011-05-01

Last updated by the study team

2019-03-20

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Denver, Colorado, United States
• Study site — Melbourne, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — South Bend, Indiana, United States
• Study site — Rockville, Maryland, United States
• Study site — Brooklyn Center, Minnesota, United States
• Study site — Edina, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Grove City, Pennsylvania, United States
• Study site — Jefferson Hills, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Upper Saint Clair, Pennsylvania, United States
• Study site — Anderson, South Carolina, United States
• Study site — Greer, South Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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