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

Phase 1CompletedNCT01999699

Dynavax Technologies Corporation25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hepatitis B

Interventions

HEPLISAVBIOLOGICAL

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Johnson County Clinical Trials

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.

Time frame: Day 1, 3, and 7 and on Day 28

Determine which of these changes correlate with the development of protective levels of antibody (anti-HBs >/= 10 milli-international unit (mIU)/mL) to hepatitis B virus (HBV).

Time frame: Day 1, 3, and 7 and on Day 28

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.