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Jennifer R. Brown, MD, PhD


Response to Shingles Vaccine Among Patients Treated With BTK Inhibitors for CLL

By: Lauren Harrison, MS
Posted: Wednesday, May 11, 2022

Patients with chronic lymphocytic leukemia (CLL) who have not been treated for their disease appear to mount stronger humoral and cellular responses to the recombinant zoster vaccine (RZV or shingles vaccine) compared with patients who have received Bruton’s tyrosine kinase (BTK) inhibitor therapy. Clare Sun, MD, of the National Institutes of Health in Bethesda, Maryland, and colleagues published this work in Blood Advances. According to the investigators, all patients with CLL ideally should receive vaccination against novel antigens before starting treatment with a BTK inhibitor.

This single-arm phase II clinical trial enrolled 116 patients with CLL who were under active surveillance or were being treated with BTK inhibitors. RZV was administered via an intramuscular injection at enrollment and after 3 months. Response to the vaccine was assessed 6 months after the first dose.

There were 106 patients evaluated for antibody response after 3 months. Patients who had not received treatment had a higher antibody response rate to the vaccine (76.8%) than those undergoing BTK inhibitor therapy (40.0%, P = .002). The cellular response rate was 70.0% in patients never treated, compared with 41.3% in those given BTK inhibition (P = .0072). Long-term responses were evaluated in 26 patients after 12 months and in 12 patients after 24 months. At the 6-month mark, 42.3% of patients had a positive serologic response, and antibody titers did not change significantly between 6, 12, and 24 months after vaccination in any subgroup.

Concordant humoral and cellular immune responses were noted in 69.1% of patients who achieved a humoral response; however, 39.0% of patients without a humoral response produced a cellular immune response (P = .0033). Neither the antibody titers nor the T-cell responses were correlated with age, absolute B- or T-cell counts, or serum immunoglobulin levels.

Common adverse events included injection-site pain (97.4%), injection-site reaction (70.7%), headache (51.7%), and generalized myalgia (51.7%). Grade 3 adverse events were noted in 14.7% of patients, and one serious adverse event (pneumonia) was unrelated to vaccine administration.

Disclosure: For a full list of authors’ disclosures, visit

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