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Trial record 1 of 11 for:    Heplisav-B | Hepatitis B
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Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04199715
Recruitment Status : Completed
First Posted : December 16, 2019
Last Update Posted : March 11, 2022
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Heplisav-B Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

A total of 18 patients will be entered into the study including 3 evenly sized groups of 6 as follows:

  • Group A patients on tumor necrosis factor alpha or interleukin inhibitor therapy for underlying chronic inflammatory disorders
  • Group B patients on chemotherapy for solid organ malignancy
  • Group C patients are either recipients of livers from anti-HBc positive donors or are patients transplanted for chronic hepatitis B infection without recurrent hepatitis B at the time of enrollment
Masking: None (Open Label)
Masking Description: N/A. Investigator and patient will know that the patient received the Heplisav-B vaccine.
Primary Purpose: Prevention
Official Title: Immunologic Efficacy of Heplisav B Vaccine in Patients Undergoing Treatment With Immunosuppressive Medications
Actual Study Start Date : December 3, 2019
Actual Primary Completion Date : January 20, 2022
Actual Study Completion Date : January 20, 2022

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04199715

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United States, Texas
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
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Principal Investigator: Robert Perrillo, MD, FAASLD Baylor Scott & White Research Institute
  Study Documents (Full-Text)

Documents provided by Baylor Research Institute:
Study Protocol  [PDF] July 17, 2019

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Responsible Party: Baylor Research Institute Identifier: NCT04199715    
Other Study ID Numbers: IND 18850
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor Research Institute:
Hepatitis B
Hep B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections