Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatitis B
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 b...
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.
Tracking Information
- NCT #
- NCT04199715
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Robert Perrillo, MD, FAASLD Baylor Scott & White Research Institute
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