Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients
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|ClinicalTrials.gov Identifier: NCT04199715|
Recruitment Status : Completed
First Posted : December 16, 2019
Last Update Posted : March 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Biological: Heplisav-B||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|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:
|Masking:||None (Open Label)|
|Masking Description:||N/A. Investigator and patient will know that the patient received the Heplisav-B vaccine.|
|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|
Experimental: Heplisav-B Vaccine Recipient
There will be a single group of 18 immune compromised patients who will receive the Heplisav-B vaccine.
This is an FDA-approved vaccine for Hepatitis B that is made by Dynavax Technologies.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04199715
|United States, Texas|
|Baylor Scott & White Research Institute|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Robert Perrillo, MD, FAASLD||Baylor Scott & White Research Institute|