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

Early Phase 1CompletedNCT03771157

University of Rochester33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia (CLL)Waldenstrom Macroglobulinemia (WM)

Interventions

Shingrix vaccineDRUG

On day one, patients will receive the first of two doses of the Shingrix vaccine 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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration

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

Time frame: 4 weeks following the second vaccination, at approximately 3 months

Secondary Outcomes

Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration

Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 4 weeks after the second vaccine administration.

Time frame: 4 weeks following the second vaccination, at approximately 3 months

Data from ClinicalTrials.gov

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