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Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors

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ClinicalTrials.gov Identifier: NCT03771157
Recruitment Status : Active, not recruiting
First Posted : December 10, 2018
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Jonathan Friedberg, University of Rochester

Brief Summary:
The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Waldenstrom Macroglobulinemia (WM) Drug: Shingrix vaccine Early Phase 1

Detailed Description:

Chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Although a recently FDA-approved recombinant, adjuvanted herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated them.

The purpose of the study is to complete a single-arm trial evaluating if patients with CLL or WM, while on treatment with first-line BTK inhibitors, can achieve immunologic response to Shingrix. If effective, this will result in a new, well-tolerated shingles prevention strategy for these patients.

The primary objective is to assess the capability to mount a humoral immune response to Shingrix in patients with CLL or WM under first-line BTK inhibitors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Serologic Response to a New Recombinant, Adjuvanted Herpes Zoster Vaccine in Patients With Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia Treated With First-Line BTK Inhibitors - A Pilot Study
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2021


Arm Intervention/treatment
Experimental: Shingrix shingles vaccine treatment
On day one, patients will receive the first of two doses of the Shingrix vaccine will be administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.
Drug: Shingrix vaccine
On day one, patients will receive the first of two doses of the Shingrix vaccine will be administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.
Other Name: Herpes Zoster Vaccine Recombinant, Adjuvanted




Primary Outcome Measures :
  1. A four-fold increase from baseline in serum immunoglobulin geometric mean titer to the gE viral antigen determined by enzyme linked immunosorbent assay (ELISA) at 4 weeks after vaccination. [ Time Frame: 4 weeks following vaccination ]
    Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects


Secondary Outcome Measures :
  1. Proportion of patients with humoral immunity at 4 weeks after vaccination [ Time Frame: 4 weeks following vaccination ]
    Blood draws performed to measure persistence of measurable anti-gE and cellular-mediated immunity; cellular-mediated response will be determined by measuring PMBC activation (by ELISPOT or flow cytometry) following stimulation with varicella glycoprotein E peptide. PBMC activation at 4 weeks and 1 year post dose will be compared to pre-vaccination activation levels.


Other Outcome Measures:
  1. A four-fold increase from baseline in serum immunoglobulin geometric mean titer to the gE viral antigen determined by enzyme linked immunosorbent assay (ELISA) at 2 years after vaccination. [ Time Frame: 2 years following vaccination ]
    Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects

  2. Proportion of patients with humoral immunity at 2 years after vaccination [ Time Frame: 2 years following vaccination ]
    Blood draws performed to measure persistence of measurable anti-gE and cellular-mediated immunity; cellular-mediated response will be determined by measuring PMBC activation (by ELISPOT or flow cytometry) following stimulation with varicella glycoprotein E peptide. PBMC activation at 4 weeks and 2 years post dose will be compared to pre-vaccination activation levels.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • They are at least 50 years of age;
  • Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM)
  • Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months,
  • Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago;
  • Have at least a one-year life expectancy;
  • Have a history of varicella (chicken-pox) OR lived in the US or any endemic country for > 30 years.
  • Prior radiation therapy is allowed

Exclusion Criteria:

  • They have a known hypersensitivity to a vaccine component;
  • Had herpes zoster reactivation within the past year;
  • Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose;
  • Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose;
  • Are unable to give informed consent;
  • Have absolute lymphocyte counts greater than 20,000 X 109/L;
  • Are receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor;
  • Had rituximab treatment within a year prior to study start;
  • Had prior chemotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771157


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14623
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Jonathan Friedberg, MD University of Rochester
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Responsible Party: Jonathan Friedberg, Director of the Wilmot Cancer Institute, University of Rochester
ClinicalTrials.gov Identifier: NCT03771157    
Other Study ID Numbers: 00003112
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jonathan Friedberg, University of Rochester:
shingles vaccine (Shingrix)
Chronic lymphocytic leukemia (CLL)
Waldenstrom macroglobulinemia (WM)
Pilot Study
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs