Phase 2 N=116 Basic Science

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)

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

Bottom Line

View on ClinicalTrials.gov: NCT03702231 ↗

Enrolled (actual)

116

Serious AEs

0.9%

Results posted

Dec 2021

Primary outcome: Primary: Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer — 43; 11; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Zoster Vaccine Recombinant, Adjuvanted (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer	43; 11; 9	—
SECONDARY Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.	1; 0; 0	—
SECONDARY Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.	0; 0; 0	—

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.

Eligibility Criteria

INCLUSION CRITERIA:
Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group
Cohort 1:Treatment naive CLL/SLL patients
Cohort 2: Subjects must be receiving treatment ibrutinib for at least 6 months prior to administration of the first vaccine dose
Cohort 3: Subjects must be receiving acalabrutinib for at least 6 months prior to administration of the first vaccine dose
No active, symptomatic VZV or herpes zoster infection within 12 months prior to vaccination
No exposure to the live VZV vaccine (ZOSTAVAX) within 12 months prior to vaccination
No prior exposure to the SHINGRIX vaccine
Age greater than or equal to 18 years.
ECOG performance status of 0-2
Able to comprehend the investigational nature of the protocol and provide informed consent

EXCLUSION CRITERIA

Female patients who are currently in pregnancy
Any uncontrolled active systemic infection
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Severe allergic reaction to any component of SHINGRIX.
Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination.
Concomitant use of immunosuppressive agents (e.g. steroids, radio

therapy, chemotherapy)

Hereditary or acquired immunodeficiency syndrome unrelated to chronic lymphocytic leukemia
Non-English speaking individuals will be excluded from the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03702231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.