Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
Condition: Safety and Tolerability; Compare SHINGRIX Vaccine Response Rates; Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
MeSH terms: Chickenpox; Herpes Zoster; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Zoster Vaccine Recombinant, Adjuvanted
Intervention description: A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ibrutinib; Acalabrutinib; Shingles; Herpes

Summary:

      Background:

      People who have cancer tend to get sick more often. This is in part because of the cancer
      treatments they get. Because of this, they may get shingles. Scientists had thought people
      with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a
      new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may
      protect people with weak immune systems from getting shingles. This is currently shown to be
      safe to give people 50 years and older to prevent shingles. Researchers want to test how safe
      the vaccine is and how it works in people with CLL.

      Objective:

      To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or
      small lymphocytic lymphoma (SLL).

      Eligibility:

      Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are
      getting certain treatments.

      Design:

      Participants will be screened with a chart review or through another protocol.

      Visit 1

      At visit 1, participants may have a pregnancy test, blood test, or physical exam.

      Pregnant participants cannot be in the study.

      Eligible participants will get the shingles vaccine as an injection.

      Participants will receive a diary and write down any symptoms they have for 7 days after the
      vaccines.

      Visit 2

      Visit 2 will be 3 months later. Participants will have blood taken and get another dose of
      the vaccine.

      Participants will receive a diary and write down any symptoms they have for 7 days after the
      vaccines.

      Visit 3

      Visit 3 will be 3 months after visit 2. Participants will have blood taken.

      Participants may be able to get an additional vaccine the same day as the shingles vaccine.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI
             Working Group

          -  Cohort 1:Treatment naive CLL/SLL patients

          -  Cohort 2: Subjects must be receiving treatment ibrutinib for at least 6 months prior
             to administration of the first vaccine dose

          -  Cohort 3: Subjects must be receiving acalabrutinib for at least 6 months prior to
             administration of the first vaccine dose

          -  No active, symptomatic VZV or herpes zoster infection within 12 months prior to
             vaccination

          -  No exposure to the live VZV vaccine (ZOSTAVAX) within 12 months prior to vaccination

          -  No prior exposure to the SHINGRIX vaccine

          -  Age greater than or equal to 18 years.

          -  ECOG performance status of 0-2

          -  Able to comprehend the investigational nature of the protocol and provide informed
             consent

        EXCLUSION CRITERIA:

          -  Female patients who are currently in pregnancy

          -  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

          -  Severe allergic reaction to any component of SHINGRIX.

          -  Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination.

          -  Concomitant use of immunosuppressive agents (e.g. steroids, radio

        therapy, chemotherapy)

          -  Hereditary or acquired immunodeficiency syndrome unrelated to chronic lymphocytic
             leukemia

          -  Non-English speaking individuals will be excluded from the study