Immune response to Shingrix vaccination in patients with chronic lymphocytic leukemia or Waldenstrom macroglobulinemia while undergoing treatment with BTK inhibitors

Serologic response to a new recombinant, adjuvanted herpes zoster vaccine in patients with chronic lymphocytic leukemia and Waldenstrom macroglobulinemia treated with first-line BTK inhibitors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78423540

Enrollment

Registered

2023-11-16

Start date

2019-02-01

Completion date

Unknown

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukemia or Waldenstrom macroglobulinemia Cancer

Interventions

Participants will receive 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 about 2 months after the fi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström macroglobulinemia (WM) 2. 50 years of age or older 3. Receiving first-line treatment with BTK inhibitor for at least 3 months; prior treatment with single-agent rituximab is permitted if the last dose was administered more than 1 year ago 4. Have at least a 1-year life expectancy 5. Have a history of varicella (chickenpox) OR lived in the US or any endemic country for >30 years

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to a vaccine component 2. Herpes zoster reactivation within the past year 3. 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 4. 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 5. Are unable to give informed consent; 6. An absolute lymphocyte count greater than 20,000 x 10e9/L 7. Receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor 8. Rituximab treatment less than one year prior to study start 9. Prior chemotherapy

Design outcomes

Primary

Measure	Time frame
Vaccine response at 4 weeks post-vaccination, as determined by serum antibody levels to the varicella virus glycoprotein E subunit (anti-gE) measured using ELISA	—

Secondary

Measure	Time frame
Vaccine response at 24 months post-vaccination, as determined by serum antibody levels to the varicella virus glycoprotein E subunit (anti-gE) measured using ELISA	—

Countries

United States of America

Contacts

Public ContactMichael Brady

michael_brady@urmc.rochester.edu+1 (0)585 276 3203

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026