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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)

NCT03702231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-08-04

Study results available
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Summary

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.

Conditions

  • Safety and Tolerability
  • Compare SHINGRIX Vaccine Response Rates
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Christopher MT Pleyer, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2020-09-09
Completion
2023-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03702231 on ClinicalTrials.gov