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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01999699

Enrollment

Registered

2013-12-03

Start date

2013-11-30

Completion date

2015-03-31

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Heplisav

Brief summary

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.

Detailed description

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

Interventions

BIOLOGICALHEPLISAV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.	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).	Day 1, 3, and 7 and on Day 28

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026