Shingrix Vaccine Response in Adults With Chronic Lymphocytic Leukemia
Studies how well the shingles vaccine works in adults with chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry title: Biological and Clinical Efficacy of Shingrix in Patients With CLL
Key facts
- Where
- Varese, ItalySee the site
Where in Italy
- UOC Ematologia ASST dei Sette LaghiVarese, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Trial code
- NCT06364033
- Record updated
- 9 May 2024
- Original description
This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.Read full original descriptionShow less
Biological and Clinical Efficacy of Recombinant Zoster Vaccine (Shingrix) in Patients With Chronic Lymphocytic Leukemia
This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.
Inclusion: Diagnosis of CLL or small lymphocytic lymphoma (SLL) or CLL-like MBL according to IWCLL guidelines. Patients must belong to one of the following subgroups:; Group A: Patients with MBL or previously untreated early-phase CLL/SLL (Binet stage A or RAI stage 0), with no clear signs of disease progression; Group B: Patients with active or symptomatic disease according to IWCLL guidelines or with advanced Binet or Rai stages receiving both the first and second vaccine doses before treatment initiation; Group C: Patients with CLL/SLL receiving targeted drugs (i.e. ibrutinib/acalabrutinib-based treatment or venetoclax-based treatment) for at least 6 months prior to the administration of the first vaccine dose; Age 18 years or older; Eligible to receive Shingrix according to clinical indication and free of charge through the Italian National Health System; Life expectancy >6 months; No active, symptomatic herpes zoster infection or varicella-zoster virus reactivation within 12 months prior to vaccination; No prior exposure to Shingrix; Able and willing to provide written informed consent and to comply with the study protocol procedures.
Exclusion: Intravenous immunoglobulin (IVIG) administration within 3 months prior to vaccination; Concomitant use of radiotherapy or chemotherapy; Chronic use of immunosuppressive medications given for indications that are not CLL-related; Any uncontrolled active systemic infection; Hereditary or acquired immunodeficiency syndrome unrelated to CLL; Female patients who are currently in pregnancy or are willing to be pregnant.