Brief Title
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
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
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.
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Proportion of patients with humoral immunity at 4 weeks after vaccination
Condition
Chronic Lymphocytic Leukemia (CLL)
Intervention
Shingrix vaccine
Study Arms / Comparison Groups
Shingrix shingles vaccine treatment
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
February 1, 2019
Completion Date
December 1, 2021
Primary Completion Date
September 1, 2020
Eligibility 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.
Gender
All
Ages
50 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jonathan Friedberg, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03771157
Organization ID
00003112
Responsible Party
Principal Investigator
Study Sponsor
University of Rochester
Study Sponsor
Jonathan Friedberg, MD, Principal Investigator, University of Rochester
Verification Date
February 2021