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Completed

NCT Number: NCT01892618

Pneumococcal Vaccine in Untreated CLL Patients

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Karolinska University Hospital

Stockholm, Stockholm County, 14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prevenar 13

Drug

13-valent pneumococcal conjugated vaccine

Pneumovax

Drug

23-valent pneumococcal polysaccharide vaccine

Primary outcomes

  1. Immune response to Pneumovax compared to immune response to Prevenar

    Time frame: 1 month post vaccination

Secondary outcomes

  1. Serotype-specific immunoglobulin G (IgG) antibody levels

    Time frame: 1 and 6 months post vaccination

    Immune response to Pneumovax vs. Prevenar13

  2. Levels of opsonophagocytic antibodies (OPA)

    Time frame: 6 months post vaccination

    Immune response

  3. Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms

    Time frame: 1 and 6 months post vaccination

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 4, 2013
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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