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)

July 18, 2023 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton s-Tyrosine Kinase Inhibitor (BTK-I) Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine the efficacy of the SHINGRIX varicella zoster virus (VZV) vaccine in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I). (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:

  • Diagnosis of CLL or SLL
  • Cohort 1: Treatment naive CLL or SLL patients
  • Cohort 2: Subjects must be receiving 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
  • Age greater than or equal to 18 years
  • ECOG performance status of 0-1

Design:

Patients with CLL will enroll on the study for the purpose of determining the SHINGRIX vaccine efficacy in patients who are treatment naive or receiving BTK-I therapy. A series of 2 doses of SHINGRIX will be given at 0- and 3- month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6 months after the first vaccine dose administration.

Study Objectives:

Primary Objective:

a)Determine the serologic response against VZV after completing the SHINGRIX (RZV) 2-

dose vaccine series in the following populations:

  • CLL patients that 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 SHINGRIX vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).

Study Type

Interventional

Enrollment (Actual)

116

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

Description

  • 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

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
Biological: Zoster Vaccine Recombinant, Adjuvanted
A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
Other Names:
  • SHINGRIX
Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
Biological: Zoster Vaccine Recombinant, Adjuvanted
A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
Other Names:
  • SHINGRIX
Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
Biological: Zoster Vaccine Recombinant, Adjuvanted
A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
Other Names:
  • SHINGRIX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer
Time Frame: 6 months after the first vaccine administration
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.
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 the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
Time Frame: 6 months after the first vaccine administration
Determine the safety and tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).
6 months after the first vaccine administration
Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
Time Frame: 6 months after the first vaccine administration
Determine the tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (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)

Investigators

  • Principal Investigator: Christopher MT Pleyer, M.D., 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)

September 9, 2020

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 11, 2018

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190001
  • 19-H-0001

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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