Chronic Lymphocytic LeukemiaPhase 3NCT01892618
Pneumococcal Vaccine in Untreated CLL Patients
A Phase 3 study testing Prevenar 13 and Pneumovax in people with Chronic Lymphocytic Leukemia, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Prevenar 13 and Pneumovax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Prevenar 13, Pneumovax
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar 13Drug
13-valent pneumococcal conjugated vaccine
PneumovaxDrug
23-valent pneumococcal polysaccharide vaccine
| Study group | Role | What they receive |
|---|---|---|
| Pneumovax | Active comparator | Pneumovax, 1x 0.5 ml injection Receives: Drug: Pneumovax |
| Prevenar 13 | Experimental | Prevenar 13, 1x 0.5 ml injection Receives: Drug: Prevenar 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response to Pneumovax compared to immune response to Prevenar
Measured: 1 month post vaccination
Secondary outcomes (3)
Serotype-specific immunoglobulin G (IgG) antibody levels
Immune response to Pneumovax vs. Prevenar13
Measured: 1 and 6 months post vaccination
Levels of opsonophagocytic antibodies (OPA)
Immune response
Measured: 6 months post vaccination
Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms
Measured: 1 and 6 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Kimby, Karolinska University Hospital
- Investigators
- Eva Kimby, Professor, Principal investigator, Karolinska University Hospital, SE-141 86 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892618
- Sponsor's protocol ID
- 2009-012642-22
- Other IDs
- 2009
- Status last verified
- Jan 2016
- First submitted
- 12 Jun 2013
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
PubMed 40396505
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01892618
- Acronym / sponsor ID
- 2009-012642-22
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumovax | Active comparator | Drug: PneumovaxPneumovax, 1x 0.5 ml injection |
| Prevenar 13 | Experimental | Drug: Prevenar 13Prevenar 13, 1x 0.5 ml injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevenar 1313-valent pneumococcal conjugated vaccine | Drug | Prevenar 13 |
| Pneumovax23-valent pneumococcal polysaccharide vaccine | Drug | Pneumovax |
Primary outcome
Immune response to Pneumovax compared to immune response to Prevenar
Time frame: 1 month post vaccination
3 secondary outcomes
Serotype-specific immunoglobulin G (IgG) antibody levels
Time frame: 1 and 6 months post vaccination
Levels of opsonophagocytic antibodies (OPA)
Time frame: 6 months post vaccination
Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms
Time frame: 1 and 6 months post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Derived from this study: PubMed 40396505Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Kimby, Professor principal investigator
Karolinska University Hospital, SE-141 86 Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prevenar 13 and Pneumovax in people with Chronic Lymphocytic Leukemia, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response to Pneumovax compared to immune response to Prevenar (time frame: 1 month post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.