Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

Phase 1

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Heplisav-B

• Registration Number: NCT04199715
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-12-03
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heplisav-B Vaccine Recipient	Heplisav-B	There will be a single group of 18 immune compromised patients who will receive the Heplisav-B vaccine.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States