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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

NCT04199715

Hepatitis B

COMPLETED PHASE1

Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

NCT00511095

Hepatitis B

COMPLETED PHASE2

Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

NCT01005407

Healthy

COMPLETED PHASE3

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

NCT02117934

Healthy

COMPLETED PHASE3

Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection

NCT04385524

Hepatitis B Virus

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HEPLISAV

Group Type EXPERIMENTAL

HEPLISAV

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HEPLISAV

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes