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CompletedNCT01892618Updated Jan 15, 2016

Pneumococcal Vaccine in Untreated CLL Patients

A Phase 3 interventional study of Prevenar 13 and Pneumovax in Chronic Lymphocytic Leukemia, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-01-15.

Sponsored by Karolinska University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Lymphocytic Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 134 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (actual)

Study arms

  • Active comparator
    Pneumovax

    Pneumovax, 1x 0.5 ml injection

    Drug: Pneumovax

  • Experimental
    Prevenar 13

    Prevenar 13, 1x 0.5 ml injection

    Drug: Prevenar 13

Interventions

  • DrugPrevenar 13

    13-valent pneumococcal conjugated vaccine

  • DrugPneumovax

    23-valent pneumococcal polysaccharide vaccine

06

What researchers measure

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

    Immune response to Pneumovax vs. Prevenar13

    Time frame: 1 and 6 months post vaccination

  2. Levels of opsonophagocytic antibodies (OPA)

    Immune response

    Time frame: 6 months post vaccination

  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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Study locations

1 site
  • Karolinska University Hospital
    Stockholm, 14186, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01892618
Lead sponsor
Karolinska University Hospital
Responsible party
Eva Kimby (Professor, Karolinska University Hospital) — Principal investigator
First posted
Jul 4, 2013
Start date
Aug 2013
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 15, 2016

Study contacts

Eva Kimby, Professor
principal investigator · Karolinska University Hospital, SE-141 86 Stockholm, Sweden

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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