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

Dynavax Technologies Corporation

Status and phase

Completed

Phase 1

Conditions

Hepatitis B

Treatments

Biological: HEPLISAV

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01999699

DV2-HBV-22

Details and patient eligibility

About

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.

Full description

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

Enrollment

25 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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