Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

February 24, 2022 updated by: Baylor Research Institute

Immunologic Efficacy of Heplisav B Vaccine in Patients Undergoing Treatment With Immunosuppressive Medications

This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Another important purpose is to test the safety of this vaccine in patients taking immune suppressive medicines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open label exploratory study of the immunologic efficacy and safety of an FDA-approved Hepatitis B vaccine called Heplisav-B. It will be used in patients treated with long term immunosuppressive drug therapy. The patients will be given two doses of Heplisav-B, the first delivered at the baseline visit and the second at week 4. Antibody levels against the Hepatitis B virus will be measured at baseline and at weeks 4, 8, 12, 24 and 60. The proportion of those patients with protective antibody levels will be compared with non-immune compromised patients receiving the same dosing schedule. Patients who fail to demonstrate protective levels of antibodies at week 8 will be given a third booster dose at week 12, and all patients will be followed to week 60.

This research is being done because current alternative hepatitis B vaccines produce lower levels of antibody to hepatitis B, and the level of antibody can be important in the prevention of the virus coming back. However, administration of Heplisav-B has been associated with higher levels of protective antibody in healthy individuals, people with diabetes, and people with kidney disease. It is hoped that the same beneficial effect of higher antibody level will also occur in patients who take an immune suppressing medicine to treat underlying inflammatory disorder (either arthritis, colitis, or chronic skin inflammation), chemotherapy for cancer, or anti-rejection therapy for liver transplantation.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older and agree to adhere to study requirements
  • Must be willing to provide informed consent
  • Serologic profile consistent with resolved hepatitis B (HBsAg negative but anti-HBc positive)
  • Must meet one of the following requirements: Recipient of anti-HBc positive liver (Group C), Chronic inflammatory disease requiring TNF or interleukin inhibitor therapy (Group A), Solid organ malignancy that requires systemic cancer chemotherapy (Group B), or Post liver transplant for chronic HBV infection (Group C).
  • Recipient of immunosuppressive drug medication as described above

Exclusion Criteria:

  • HBsAg positivity
  • Anti-HBs level > 20 mIU/mL at baseline
  • HIV infection
  • HCV infection
  • Prior hepatitis B vaccination
  • Received hepatitis B immune globulin during the past 4 months
  • Hematologic malignancy
  • Hepatocellular carcinoma
  • Active alcohol use > 20 grams daily
  • Unstable underlying inflammatory disorder
  • Pregnancy or breast feeding
  • History of severe depression or other severe psychiatric disorder
  • Received liver transplant < 3 years earlier
  • Transplant rejection within the past year
  • Unstable or poorly responsive inflammatory disorders
  • Patients who have an unreasonable risk of complications
  • Anticipated life expectancy less than one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Heplisav-B Vaccine Recipient
There will be a single group of 18 immune compromised patients who will receive the Heplisav-B vaccine.
Biological: Heplisav-B
This is an FDA-approved vaccine for Hepatitis B that is made by Dynavax Technologies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Heplisav-B Vaccine in Immunosuppressed Patients
Time Frame: 60 weeks
Patients will be followed for 60 weeks to capture adverse events. Safety will be determined by the proportion of patients with unsolicited adverse events after vaccine administration, the proportion of patients with serious adverse events, the proportion of patients with medically attended adverse events, the proportion of patients with potentially immune-mediated medical conditions, and the proportion of patients who need an increase in immune suppressive medication.
60 weeks
Immunologic Efficacy of Heplisav-B Vaccine in Immunosuppressed Patients
Time Frame: 60 weeks
Efficacy will be determined by the proportion of patients who respond with seroprotective levels (> 10 mIU/ml) of anti-HBs at each study interval and the proportion of patients with anti-HBs titers > 100 mIU/ml at each study interval.
60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Robert Perrillo, MD, FAASLD, Baylor Scott & White Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 3, 2019

Primary Completion (ACTUAL)

January 20, 2022

Study Completion (ACTUAL)

January 20, 2022

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (ACTUAL)

December 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 18850

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on Heplisav-B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe