Biological and Clinical Efficacy of Shingrix in Patients With CLL
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Study ID
- NCT06364033
- Status
- Not Yet Recruiting
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Conditions
- CLL-like MBL
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Varicella-zoster Virus Reactivation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- serologic response evaluation — BIOLOGICALBlood samples collection
Study Details
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.
Key Dates
- First listed
- Apr 15, 2024
- Start date
- Aug 31, 2024
- Status verified
- May 2024
- Primary completion
- Nov 30, 2025
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 312 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Primary Outcome Measure
Serologic response evaluation [ Time Frame: at 1 month ]
Central Contacts
- Paola Fazi0670390528
- Enrico Crea0670390514
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