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|
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : April 19, 2019
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.
To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL).
Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments.
Participants will be screened with a chart review or through another protocol.
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 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 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||Biological: Zoster VaccineRecombinant, Adjuvanted||Phase 2|
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
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.
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)
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)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||May 15, 2020|
|Estimated Study Completion Date :||May 15, 2020|
Experimental: Arm 1
Patients with CLL
Biological: Zoster VaccineRecombinant, Adjuvanted
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 on a 0- and 3-month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose. SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
- Response to the SHINGRIX vaccine in untreated CLL patients and CLL patients treated with BTK-inhibitors [ Time Frame: 6 months after the first vaccine administration ]Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement following completion of the SHINGRIX 2-dose vaccine series in CLL patients that are treatment naive or receiving therapy with a BTK-inhibitor
- Safety and Tolerabilty of the SHINGRIX vax in CLL pts. [ Time Frame: 6 months after the first vaccine administration ]Determine the safety and tolerability of the SHINGRIXvaccine among CLL patients who are treatment naive or receiving a Bruton s-tyrosine kinase inhibitor (BTK-I) (ibrutinib or acalabrutinib).
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
|Contact: Susan Soto, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Christopher MT Pleyer, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|