NCT03771157 · REGISTRY CONDITION SEARCH

Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: EARLY PHASE1
Status at capture: COMPLETED
Registry last update: 2024-03-15

The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration

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outcome · POSTED

Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration

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outcome · POSTED

Number of Participants With Humoral Response to Vaccination 2 Years After the Second Vaccine Administration

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outcome · POSTED

Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * They are at least 50 years of age; * Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM) * Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months, * Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago; * Have at least a one-year life expectancy; * Have a history of varicella (chicken-pox) OR lived in the US or any endemic country for \> 30 years. * Prior radiation therapy is allowed Exclusion Criteria: * They have a known hypersensitivity to a vaccine component; * Had herpes zoster reactivation within the past year; * Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose; * Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose; * Are unable to give informed consent; * Have absolute lymphocyte counts greater than 20,000 X 109/L; * Are receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor; * Had rituximab treatment within a year prior to study start; * Had prior chemotherapy.
healthy Volunteers: false
minimum Age: 50 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.
intervention Names
Drug: Shingrix vaccine
label
Shingrix shingles vaccine treatment
type
EXPERIMENTAL

interventions

arm Group Labels
Shingrix shingles vaccine treatment
description
On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.
name
Shingrix vaccine
other Names
Herpes Zoster Vaccine Recombinant, Adjuvanted
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 33
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects
measure
Number of Participants With Humoral Response to Vaccination 2 Years After the Second Vaccine Administration
time Frame
2 years following second vaccination, approximately 26 months from day 1
description
Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 2 years after the second vaccine administration.
measure
Number of Participants With Cellular Response to Vaccination 2 Years After the Second Vaccine Administration
time Frame
2 years following second vaccination, approximately 26 months from day 1

primary Outcomes

description
Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects
measure
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
time Frame
4 weeks following the second vaccination, at approximately 3 months

secondary Outcomes

description
Cellular response, as determined by measuring VZgE-specific T-cell responses in blood, 4 weeks after the second vaccine administration.
measure
Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration
time Frame
4 weeks following the second vaccination, at approximately 3 months

Full study description

brief Summary: The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.
detailed Description: Chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Although a recently FDA-approved recombinant, adjuvanted herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated them. The purpose of the study is to complete a single-arm trial evaluating if patients with CLL or WM, while on treatment with first-line BTK inhibitors, can achieve immunologic response to Shingrix. If effective, this will result in a new, well-tolerated shingles prevention strategy for these patients. The primary objective is to assess the capability to mount a humoral immune response to Shingrix in patients with CLL or WM under first-line BTK inhibitors.

Source references

Source notices and limitations

Discovery and provenance

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query disease state id
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source url
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Preserved source evidence · Not medical advice