Hepatitis B
Conditions
Keywords
Hepatitis B, Hep B, Vaccine, Immunosuppression, HBV
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.
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.
Interventions
BIOLOGICALHeplisav-B
This is an FDA-approved vaccine for Hepatitis B that is made by Dynavax Technologies.
Sponsors
Baylor Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
N/A. Investigator and patient will know that the patient received the Heplisav-B vaccine.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Heplisav-B Vaccine in Immunosuppressed Patients | 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. |
| Immunologic Efficacy of Heplisav-B Vaccine in Immunosuppressed Patients | 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. |
Countries
United States
Outcome results
None listed