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| ID | Type | Description | Link |
|---|---|---|---|
| 19-H-0001 |
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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.
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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Lymphocytic Leukemia Patients That Are Treatment Naive | Experimental | 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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| Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib | Experimental | 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. |
|
| Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine Recombinant, Adjuvanted | Biological | A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer | 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. | 6 months after the first vaccine administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. | 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). | 6 months after the first vaccine administration |
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EXCLUSION CRITERIA:
therapy, chemotherapy)
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| Name | Affiliation | Role |
|---|---|---|
| Christopher MT Pleyer, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35157769 | Derived | Pleyer C, Laing KJ, Ali MA, McClurkan CL, Soto S, Ahn IE, Nierman P, Maddux E, Lotter J, Superata J, Tian X, Wiestner A, Cohen JI, Koelle DM, Sun C. BTK inhibitors impair humoral and cellular responses to recombinant zoster vaccine in CLL. Blood Adv. 2022 Mar 22;6(6):1732-1740. doi: 10.1182/bloodadvances.2021006574. | |
| 33259596 | Derived |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2020 |
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|
| Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. | 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). | 6 months after the first vaccine administration |
| Pleyer C, Ali MA, Cohen JI, Tian X, Soto S, Ahn IE, Gaglione EM, Nierman P, Marti GE, Hesdorffer C, Lotter J, Superata J, Wiestner A, Sun C. Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines. Blood. 2021 Jan 14;137(2):185-189. doi: 10.1182/blood.2020008758. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer | 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. | 116 patients enrolled in study and 106 patients were analyzed. 10 patients did not complete study. | Posted | Count of Participants | Participants | 6 months after the first vaccine administration |
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|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. | 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). | Posted | Count of Participants | Participants | 6 months after the first vaccine administration |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients. | 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). | Posted | Count of Participants | Participants | 6 months after the first vaccine administration |
|
Events will be collected for 7 days following the first and second vaccine dose
All events whether volunteered by the subject, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 58 | 1 | 58 | 58 | 58 |
| EG001 | 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. 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. | 0 | 30 | 0 | 30 | 29 | 30 |
| EG002 | 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. 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. | 0 | 28 | 0 | 28 | 27 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Myalgia | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vaccination complication | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vaccination site lymphadenopathy | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Pleyer, M.D. Principal Investigator, NIH, NHLBI | National Institutes of Health (NIH) / The National Heart, Lung, and Blood Institute (NHLBI) | 510.709.6649 | christopher.pleyer@nih.gov |
| Mar 8, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D006562 | Herpes Zoster |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 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. 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. |
|
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| 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. 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. |
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