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

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.

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.