A Study of the Immune Response to Heplisav in Healthy Older Adults

Completed · Phase 1

Conditions studied: Hepatitis B

In brief

This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.

Key facts

Study ID

NCT01999699

Run by

Dynavax Technologies Corporation

People needed

25

Starts

2013-11-01

Expected to finish

2015-03-01

Last updated by the study team

2019-03-20

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 50 to 70 years of age, inclusive
• In good health in the opinion of the principal investigator, based upon medical history and physical examination
• Serum negative for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
• If female of childbearing potential, agree to consistently use a highly effective method of birth control from the screening visit through Week 12/Visit 10

You may not qualify if…

• Pregnant, breastfeeding, or planning a pregnancy
• Known history of an autoimmune disease
• Previously received any hepatitis B vaccine (approved or investigational)
• Body-mass index (BMI) >30 kg/m2, diabetes mellitus (type 1 or 2), or other chronic medical condition that in the opinion of the principal investigator might interfere with the immune response to hepatitis B vaccination

Where it is running

• Johnson County Clinical Trials — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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