HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
Condition: Hepatitis; Safety and Tolerability
MeSH terms: Hepatitis A; Hepatitis B; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hepatitis
Intervention: HEPLISAV-B
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ibrutinib; Acalabrutinib; Immunology

Summary:

      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.
    

Eligibility criteria:

        -  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