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)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | December 7, 2018 |
| End Date: | May 15, 2020 |
| Contact: | Sarah E Herman, Ph.D. |
| Email: | hermanse@mail.nih.gov |
| Phone: | (301) 496-5328 |
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
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 sumptoms 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.
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 sumptoms 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.
This study aims to determine the efficacy of 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.
Key Eligibility Criteria:
- Diagnosis of CLL
- Cohort 1: Treatment naive CLL patients
- Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior
to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib monotherapy 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).
vaccine in chronic lymphocytic leukemia (CLL) patients that are treatment naive or receiving
Bruton s-tyrosine kinase inhibitor (BTK-I) therapy.
Key Eligibility Criteria:
- Diagnosis of CLL
- Cohort 1: Treatment naive CLL patients
- Cohort 2: Subjects must be receiving ibrutinib monotherapy for at least 6 months prior
to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib monotherapy 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).
- INCLUSION CRITERIA:
- Diagnosis of CLL
- Cohort 1:Treatment na1ve CLL 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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