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Pneumococcal Vaccine in Untreated CLL Patients

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ClinicalTrials.gov Identifier: NCT01892618
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Eva Kimby, Karolinska University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Prevenar 13 Drug: Pneumovax Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Active Comparator: Pneumovax
Pneumovax, 1x 0.5 ml injection
Drug: Pneumovax
23-valent pneumococcal polysaccharide vaccine

Experimental: Prevenar 13
Prevenar 13, 1x 0.5 ml injection
Drug: Prevenar 13
13-valent pneumococcal conjugated vaccine




Primary Outcome Measures :
  1. Immune response to Pneumovax compared to immune response to Prevenar [ Time Frame: 1 month post vaccination ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892618


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Eva Kimby, Professor Karolinska University Hospital, SE-141 86 Stockholm, Sweden

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Responsible Party: Eva Kimby, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01892618     History of Changes
Other Study ID Numbers: 2009-012642-22
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs