HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)

January 13, 2022 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Response to the HEPLISAV-B Hepatitis B Vaccine in Treatment Naive Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's -Tyrosine Kinase Inhibitor (BTK-I)

Background:

People with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) tend to get infections more easily. This is because their immune systems are weakened. Hepatitis B is a virus that can be transmitted when body fluids from an infected person enter the body of an uninfected person. This virus can be dangerous for people with leukemia and lymphoma. HEPLISAV-B is a new hepatitis B vaccine. Researchers want to see if it can protect people with CLL/SLL from getting hepatitis B.

Objective:

To learn how HEPLISAV-B works in people who have CLL or SLL.

Eligibility:

Adults 18 years and older with CLL (or SLL). They must be getting no treatment for their CLL, or getting ibrutinib or acalabrutinib for it.

Design:

This study lasts 6 months from the date of first vaccination.

Participants may be screened with:

Physical exam

Blood tests

Pregnancy test

Visit 1

Participants will get blood drawn and the study vaccine. It will be given as an injection. If they get any symptoms within 7 days of the vaccine, they will write them in a diary.

Visit 2

After 3 months, participants will come back to the NIH to get another blood draw and the second vaccine dose.

Visit 3

Participants will return 3 months after the second vaccine dose was given. They will have blood drawn.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine the HEPLISAV-B hepatitis B vaccine efficacy in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) lymphocytic patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I) therapy. (Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified).

Key Eligibility Criteria:

  1. Diagnosis of CLL
  2. Cohort 1: Treatment naive CLL or SLL patients
  3. Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose
  4. Cohort 3: Subjects must be receiving acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose
  5. No known active or past hepatitis B infection
  6. No history of prior hepatitis B virus vaccination (approved or investigational)
  7. Age greater greater than or equal to 18 years.
  8. ECOG performance status of 0-1

Design:

Patients with CLL will enroll on the study for the purpose of determining the HEPLISAV-B vaccine efficacy in patients who are treatment naive ore receiving BTK-I therapy. A series of 2 doses of HEPLISAV-B will be given on a 0- and 3- month schedule by intramuscular injection. Subjects will be followed at regular intervals and receive serologic response assessment following completion of the HEPLISAV-B vaccine series (6 months after the first vaccine

administration).

Study Objectives:

Primary Objective:

a) Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs greater than or equal to 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) in the following populations:

  • CLL patients who are treatment naive (n=54)
  • CLL patients receiving treatment with ibrutinib (n=27)
  • CLL patients receiving treatment with acalabrutinib (n=27)

Secondary Objective:

a) Determine the safety and tolerability of the HEPLISAV-B vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group.
  • No known active or past hepatitis B infection
  • No history of prior hepatitis B virus vaccination (approved or investigational)
  • History of negative hepatitis B viral titers (negative HBsAg, HBsAb and HBcAb)
  • Cohort 1: Treatment naive CLL patients
  • Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose
  • Cohort 3: Subjects must be receiving acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose
  • Age greater than or equal to 18 years.
  • ECOG performance status of 0-1
  • Able to comprehend the investigational nature of the protocol and provide informed consent.

EXCLUSION CRITERIA:

  • Female patients who are currently pregnant.
  • Any uncontrolled active systemic infection
  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk
  • History of severe allergic reaction to any component of HEPLISAV-B, including yeast
  • Receive intravenous or subcutaneous immunoglobulin (IVIG) within 3 months prior to vaccination
  • Concomitant use of immunosuppressive agents (e.g. steroids, radiotherapy, chemotherapy)
  • Hereditary or acquired immunodeficiency syndrome unrelated to CLL
  • Non-English speaking individuals will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic Lymphocytic Leukemia Patients That Are Treatment Naïve
Treatment naïve Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL) patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
Biological: HEPLISAV-B
HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Ibrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
Biological: HEPLISAV-B
HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
Acalabrutinib monotherapy for at least 6 months prior to administration of the first vaccine dose in patients with Chronic Lymphocytic Leukemia (CLL) or small lymphocytic lymphoma (SLL). Patients will receive HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
Biological: HEPLISAV-B
HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With HEPLISAV-B Seroprotective Titer (Anti-HBs 10mIU/mL)
Time Frame: 6 months after the first vaccine administration
Determine the rate of hepatitis B seroprotective titer achievement (anti-HBs 10mIU/mL) following completion of the HEPLISAV-B 2-dose vaccine series (6 months after the first vaccine administration) among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
6 months after the first vaccine administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Experienced Serious Adverse Events Following HEPLISAV-B Vaccine Among CLL Patients
Time Frame: 6 months after the first vaccine administration
Determine the safety of the HEPLISAV-B vaccine among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
6 months after the first vaccine administration
Number of Participants That Did Not Complete Study Due to Intolerance of the HEPLISAV-B Vaccine Among CLL Patients.
Time Frame: 6 months after the first vaccine administration
Determine the tolerability of the HEPLISAV-B vaccine among chronic lymphocytic leukemia (CLL) patients who are treatment naïve or receiving Bruton Tyrosine Kinase (BTK) inhibitors (Ibrutinib or Acalabrutinib).
6 months after the first vaccine administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2018

Primary Completion (Actual)

December 16, 2020

Study Completion (Actual)

December 16, 2020

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180145
  • 18-H-0145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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