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Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Treatment Na(SqrRoot) ve 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 : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief 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. t 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.

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.

Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine.

Participants will write down any symptoms they have for 7 days after the vaccines.

Participants may be able to get an additional vaccine the same day as the shingles vaccine.

Visit 3 will be 3 months after visit 2. Participants will have blood taken.


Condition or disease Intervention/treatment Phase
Safety and Tolerability Compare SHINGRIX Vaccine Response Rates Biological: Zoster VaccineRecombinant, Adjuvanted Phase 2

Detailed Description:

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 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.

Study Objectives:

Primary Objective:

a) Determine the rate of VZV seroprotective titer achievement following completion of the SHINGRIX (RZV) 2-dose vaccine series (6 months after the first vaccine administration) 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)
Estimated Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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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
Criteria
  • INCLUSION CRITERIA:
  • Diagnosis of CLL
  • Cohort 1: Subjects must currently be receiving no CLL directed therapy (active surveillance) for at least 4 weeks prior to administration of the first vaccine dose
  • 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
  • Age greater than or equal to 18 years.
  • ECOG performance status of 0-2

EXCLUSION CRITERIA:

  • Severe allergic reaction to any component of SHINGRIX.
  • Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination.
  • Concomitant immunosuppressing therapy, including chemotherapy, daily steroid administration equivalent to greater than or equal to 20mg of prednisone, radiotherapy or other immunosuppressive agents
  • Human immunodeficiency virus infection or other hereditary or acquired immunodeficiency syndrome unrelated to chronic lymphocytic leukemia
  • Active, symptomatic VZV or herpes zoster infection within 6 months prior to vaccination
  • Prior exposure to the SHINGRIX vaccine

Information from the National Library of Medicine

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


Contacts
Contact: Christopher MT Pleyer, M.D. (301) 402-2399 christopher.pleyer@nih.gov

Locations
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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Christopher MT Pleyer, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03702231     History of Changes
Other Study ID Numbers: 190001
19-H-0001
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: November 26, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Ibrutinib
Acalabrutinib
Shingles
Herpes

Additional relevant MeSH terms:
Herpes Zoster
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Chickenpox
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs