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

A Phase 1 Systems Biology Study to Investigate Immune Correlates of the Response to an Experimental Hepatitis B Vaccine (HEPLISAV) in Healthy Adults 50 to 70 Years of Age.

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.

The purpose of this study is to examine how the immune system responds to vaccination with HEPLISAV.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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