Pneumococcal Vaccine in Untreated CLL Patients

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01892618

Enrollment

134

Registered

2013-07-04

Start date

2013-08-31

Completion date

2015-12-31

Last updated

2016-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

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.

Interventions

DRUGPrevenar 13

13-valent pneumococcal conjugated vaccine

DRUGPneumovax

23-valent pneumococcal polysaccharide vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Immune response to Pneumovax compared to immune response to Prevenar	1 month post vaccination

Secondary

Measure	Time frame	Description
Serotype-specific immunoglobulin G (IgG) antibody levels	1 and 6 months post vaccination	Immune response to Pneumovax vs. Prevenar13
Levels of opsonophagocytic antibodies (OPA)	6 months post vaccination	Immune response
Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms	1 and 6 months post vaccination	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026