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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heplisav-B Vaccine Recipient | Experimental | There will be a single group of 18 immune compromised patients who will receive the Heplisav-B vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heplisav-B | Biological | This is an FDA-approved vaccine for Hepatitis B that is made by Dynavax Technologies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Heplisav-B Vaccine in Immunosuppressed Patients | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Perrillo, MD, FAASLD | Baylor Scott & White Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White Research Institute | Dallas | Texas | 75246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29939980 | Background | Schillie S, Vellozzi C, Reingold A, Harris A, Haber P, Ward JW, Nelson NP. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018 Jan 12;67(1):1-31. doi: 10.15585/mmwr.rr6701a1. | |
| 28128861 | Background | Paul S, Dickstein A, Saxena A, Terrin N, Viveiros K, Balk EM, Wong JB. Role of surface antibody in hepatitis B reactivation in patients with resolved infection and hematologic malignancy: A meta-analysis. Hepatology. 2017 Aug;66(2):379-388. doi: 10.1002/hep.29082. Epub 2017 Jun 22. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2019 | Feb 24, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C000726347 | Heplisav-B |
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A total of 18 patients will be entered into the study including 3 evenly sized groups of 6 as follows:
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N/A. Investigator and patient will know that the patient received the Heplisav-B vaccine.
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| 30090877 | Background | Splawn LM, Bailey CA, Medina JP, Cho JC. Heplisav-B vaccination for the prevention of hepatitis B virus infection in adults in the United States. Drugs Today (Barc). 2018 Jul;54(7):399-405. doi: 10.1358/dot.2018.54.7.2833984. |
| 37353450 | Derived | Perrillo R, Garrido LF, Ma TW, Rahimi R, Lilly B. Vaccination with HepB-CpG vaccine in individuals undergoing immune suppressive drug therapy. Vaccine. 2023 Jul 12;41(31):4457-4461. doi: 10.1016/j.vaccine.2023.06.041. Epub 2023 Jun 21. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |