Biological and Clinical Efficacy of Shingrix in Patients With CLL

April 9, 2024 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-centre, prospective study, performed on biological samples only. 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. All protocol procedures (including clinical assessment and blood draws) will be performed during regular follow-up visits according to clinical practice. No additional invasive/dangerous/painful procedures will be required by the study.

Study Type

Interventional

Enrollment (Estimated)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Varese, Italy
        • UOC Ematologia ASST dei Sette Laghi
        • Contact:
          • Marta Coscia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Diagnosis of CLL or small lymphocytic lymphoma (SLL) or CLL-like MBL according to IWCLL guidelines (1). Patients must belong to one of the following subgroups: Group A: Patients with MBL or previously untreated early-phase CLL (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 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 Criteria:

  • Female patients who are currently in pregnancy or are willing to be pregnant
  • Any uncontrolled active systemic infection
  • Intravenous immunoglobulin (IVIG) administration within 3 months prior to vaccination
  • Concomitant use of radiotherapy or chemotherapy
  • Hereditary or acquired immunodeficiency syndrome unrelated to CLL
  • Chronic use of immunosuppressive medications given for indications that are not CLL-related

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serologic response evaluation
Time Frame: at 1 month
Rate of positive serologic response to Shingrix in different subsets of patients as determined by antibody response to varicella-zoster virus (≥4-fold increase in anti-gE titer from baseline)
at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Marta Coscia, UOC Ematologia ASST Sette Laghi Varese

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL2624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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