Pneumococcal Vaccine in Untreated CLL Patients

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Randomized Phase III Trial to Determine Whether Conjugated Pneumococcal Vaccine Can Improve the Immune Responsiveness Compared to Polyclonal Pneumococcal Vaccine in Patients With Untreated Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892618
• Other study ID #: 2009-012642-22
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2013
• Last updated: January 14, 2016
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms of immune response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Untreated CLL patients all Rai stages (0 to IV), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and/or chemotherapy

Exclusion Criteria:

• Immunosuppressive therapy planned to start within 1 month

• Other malignancies

• Corticosteroids or other immunosuppressive drugs

• Previous allergic reaction to any vaccination in the past

• Neutropenia (PMNs < 500 cells/mm3)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Prevenar 13
13-valent pneumococcal conjugated vaccine
• Pneumovax
23-valent pneumococcal polysaccharide vaccine

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response to Pneumovax compared to immune response to Prevenar		1 month post vaccination	No
Secondary	Serotype-specific immunoglobulin G (IgG) antibody levels	Immune response to Pneumovax vs. Prevenar13	1 and 6 months post vaccination	No
Secondary	Levels of opsonophagocytic antibodies (OPA)	Immune response	6 months post vaccination	No
Secondary	Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms		1 and 6 months post vaccination	No