Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

NCT04199715 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IND 18850
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Keywords

Hepatitis B; Hep B; Vaccine; Immunosuppression; HBV

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Heplisav-B Vaccine Recipient

EXPERIMENTAL

There will be a single group of 18 immune compromised patients who will receive the Heplisav-B vaccine.

Biological: Heplisav-B

Interventions

Heplisav-B BIOLOGICAL

This is an FDA-approved vaccine for Hepatitis B that is made by Dynavax Technologies.

Heplisav-B Vaccine Recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

Related Publications (4)

• 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.

  PMID: 29939980 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.

  PMID: 28128861 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.

  PMID: 30090877 BACKGROUND

• 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.

  PMID: 37353450 DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Heplisav-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Robert Perrillo, MD, FAASLD

  Baylor Scott & White Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: N/A. Investigator and patient will know that the patient received the Heplisav-B vaccine.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: December 3, 2019
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-02

Locations

US (1)