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)
CompletedPhase 2Results postedLast updated 4 August 2023
What this trial tests
Phase 2 trial testing Zoster Vaccine Recombinant, Adjuvanted in Safety and Tolerability in 116 participants. Completed in 12 July 2023.
Adults 18 to 99, any sex, with Safety and Tolerability or Compare SHINGRIX Vaccine Response Rates. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Varicella Zoster Virus (VZV) Seroprotective TiterPrimary· 6 months after the first vaccine administration
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold ris
Group
Value
95% CI
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
43
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
11
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
9
Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.Secondary· 6 months after the first vaccine administration
Determine the safety and tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).
Group
Value
95% CI
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
1
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
0
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
0
Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.Secondary· 6 months after the first vaccine administration
Determine the tolerability of the SHINGRIX vaccine among Chronic Lymphocytic Leukemia (CLL) patients who are treatment naïve or receiving a Brutons-tyrosine kinase inhibitor (BTK-I) (Ibrutinib or Acalabrutinib).
Group
Value
95% CI
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
0
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
0
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Events will be collected for 7 days following the first and second vaccine dose.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
Serious: 1/58 (2%)
Deaths: 0/58
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Serious: 0/30 (0%)
Deaths: 0/30
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti
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NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 4 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03702231.