BETHESDA, MD – Because of immune dysregulation, chronic lymphocytic leukemia patients are especially vulnerable to infectious complications, including varicella zoster virus reactivation.
Both their advanced age and immunocompromised status play a role in higher risk for shingles, according to a presentation at the 61st American Society of Hematology Annual Meeting and Exposition in Orlando, FL.1
National Institutes of Health researchers pointed out that a new recombinant (non-live) adjuvanted shingles vaccine, marketed as Shingrix, has the potential to reduce VZV reactivation, without the risk of giving a live vaccine to immunocompromised individuals.
RZV is proven to reduce the risks of herpes zoster and postherpetic neuralgia in healthy adults 50 and older. Its efficacy in immunocompromised individuals, including CLL, remains unknown, however, leading to the investigation of the preliminary safety and efficacy of RZV in treated and untreated CLL patients.
Participants in the phase II open-label study were patients with CLL who were either treatment naïve or receiving treatment with a Bruton’s tyrosine kinase inhibitor (BTK-I) (ibrutinib or acalabrutini). They received two doses of RZV via intramuscular injection at 0- and 3-months.
Researchers followed the patients for 6 months and assessed serologic response at 3- and 6-months. Based on results of prior published studies, serologic response was defined as a four-fold rise in VZV anti-glycoprotein E (anti-gE) blood IgG serum titer or greater after completing the RZV vaccine series.
Participants also completed an adverse event diary documenting any injection site or systemic AE that started within 7 days after receiving the first and second vaccine dose.
Researchers reported safety data that was available on 57 subjects who received at least one vaccine dose as of the time of the publication of the abstract. The most frequent local and systemic AEs were injection site pain (67%), injection site reaction (32%) and generalized myalgias (25%) (Table 1).
In fact, the study found that all adverse reactions were grade 1-2, except for 2 (4%) grade 3 reactions. No serious AEs were reported, and all of those events resolved or returned to baseline within 7 days of vaccine administration.
“Seven subjects have completed the primary endpoint and have had serologic response assessment at 6-months,” the authors reported. “Serologic responses were observed in 3 (43%) patients. All patients (n = 7) achieved ≥ 2.2-fold rise in VZV anti-gE titers at 6-months. Preliminary analysis of 3-month samples (n = 43) shows early evidence of increasing titers after the first dose of RZV.”
Researchers concluded that RZV administration appears to be safe in CLL patients that are treatment naïve or receiving treatment with a BTK-I, adding, “Compared to previously reported toxicities in the healthy population, no increase in frequency or severity of AEs were observed. Preliminary data suggests that RZV induces humoral immune responses in patients with CLL.”
- Pleyer C, Cohen J, Soto S, Ali M, et. Al. Response to the Shingrix Varicella Zoster Virus (VZV) Vaccine in Patients with Chronic Lymphocytic Leukemia (CLL) That Are Treatment Naive or Treated with a Bruton’s Tyrosine Kinase Inhibitor (BTK-I). Presented at the 61st American Society of Hematology Annual Meeting and Exposition; December 2019; Orlando, FL