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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771157
• Other study ID #: 00003112
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2019
• Est. completion date: August 3, 2022

Study information

• Verified date: February 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 3, 2022
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Waldenstrom Macroglobulinemia
• Waldenstrom Macroglobulinemia (WM)

Intervention

Drug:
• Shingrix vaccine
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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Humoral Response to Vaccination 2 Years 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	2 years following second vaccination, approximately 26 months from day 1
Other	Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration	Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 2 years after the second vaccine administration.	2 years following second vaccination, approximately 26 months from day 1
Primary	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	4 weeks following the second vaccination, at approximately 3 months
Secondary	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.	4 weeks following the second vaccination, at approximately 3 months