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)
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| ClinicalTrials.gov Identifier: NCT03702231 |
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Recruitment Status :
Active, not recruiting
First Posted : October 11, 2018
Results First Posted : December 15, 2021
Last Update Posted : January 14, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Safety and Tolerability Compare SHINGRIX Vaccine Response Rates Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) | Biological: Zoster Vaccine Recombinant, Adjuvanted | Phase 2 |
This study aims to determine the efficacy of the SHINGRIX varicella zoster virus (VZV) vaccine in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I). (Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified).
Key Eligibility Criteria:
- Diagnosis of CLL or SLL
- Cohort 1: Treatment naive CLL or SLL patients
- Cohort 2: Subjects must be receiving 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
- Age greater than or equal to 18 years
- ECOG performance status of 0-1
Design:
Patients with CLL will enroll on the study for the purpose of determining the SHINGRIX vaccine efficacy in patients who are treatment naive or receiving BTK-I therapy. A series of 2 doses of SHINGRIX will be given at 0- and 3- month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6 months after the first vaccine dose administration.
Study Objectives:
Primary Objective:
a)Determine the serologic response against VZV after completing the SHINGRIX (RZV) 2-
dose vaccine series in the following populations:
- CLL patients that are treatment naive (n=54)
- CLL patients receiving treatment with ibrutinib (n=27)
- CLL patients receiving treatment with acalabrutinib (n=27)
Secondary Objective:
a) Determine the safety and tolerability of the SHINGRIX vaccine among CLL patients who are treatment naive or receiving BTK-Is (ibrutinib or acalabrutinib).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton s-Tyrosine Kinase Inhibitor (BTK-I) Therapy |
| Actual Study Start Date : | December 7, 2018 |
| Actual Primary Completion Date : | September 9, 2020 |
| Estimated Study Completion Date : | July 12, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
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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.
Other Name: SHINGRIX |
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Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
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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.
Other Name: SHINGRIX |
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Experimental: Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
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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.
Other Name: SHINGRIX |
- Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer [ Time Frame: 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 rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.
- Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. [ Time Frame: 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).
- Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. [ Time Frame: 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).
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702231
| United States, Maryland | |
| National Institutes of Health Clinical Center | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Christopher MT Pleyer, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Documents provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT03702231 |
| Other Study ID Numbers: |
190001 19-H-0001 |
| First Posted: | October 11, 2018 Key Record Dates |
| Results First Posted: | December 15, 2021 |
| Last Update Posted: | January 14, 2022 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ibrutinib Acalabrutinib Shingles Herpes |
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Chickenpox Herpes Zoster Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Varicella Zoster Virus Infection Herpesviridae Infections DNA Virus Infections Virus Diseases Infections |