Clinical trial · Interventional
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
Serologic Response to a New Recombinant, Adjuvanted Herpes Zoster Vaccine in Patients With Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia Treated With First-Line BTK Inhibitors - A Pilot Study
NCT03771157CI-TRIAL-00075035completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Waldenstrom Macroglobulinemia (WM) | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shingrix vaccine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: Shingrix vaccine
Primary outcomes (1)
- measure
- Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
- timeFrame
- 4 weeks following the second vaccination, at approximately 3 months
- 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
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.