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Chronic Lymphocytic LeukemiaPhase 2NCT05417165

Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Pneumococcal 20-valent Conjugate Vaccine and Pneumococcal Polyvalent Vaccine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Seema Bhat at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial compares the effect of initial vaccination (PCV20 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pneumococcal 20-valent Conjugate Vaccine and Pneumococcal Polyvalent Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
29 Sep 2023to 31 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women >= 18 years of age
  • Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms
  • Treatment naive CLL/SLL; No prior therapy for CLL/SLL, including chemotherapy and/or radiotherapy is allowed
  • Estimated life expectancy of greater than 24 months

Who cannot join

  • Patients with neutropenic (granulocyte [PMN]s < 500 cells/mm^3) or having received rituximab within 6 months
  • Patients with fever (temperature > 38 degrees Celsius [C]) within 1 week
  • Active infection, recent infection requiring systemic treatment that was completed =< 14 days before starting treatment on the study
  • Patients with known human immunodeficiency virus (HIV) infection
  • History of allergic reactions attributable to compounds of similar chemical or biologic composition to any component of pneumococcal vaccines
  • Chemotherapy in 4 weeks or received Rituximab or similar anti CD20 monoclonal antibody for non-hematological indications within 6 months
Show all 19Show fewer
  • Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination
  • History of allogenic stem cell transplantation
  • Patients who have received cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
  • Patients who have previously received pneumococcal vaccine within the preceding 12 months
  • Absolute lymphocyte count less than 500 cells/mm^3
  • Patient with other severe immune deficiency
  • Patients may not be receiving any other investigational agents
  • Active malignancy from which the subject is considered by his or her physician to have a less than 24 month survival expectation. Non-melanoma skin cancer is not an exclusion criterion.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and/or psychiatric illness/social situations that would limit compliance with study requirements
  • Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 20 mg/day of prednisone) within 14 days of the first dose of study drug
  • Because of the potential for H2-blockers to modulate antibody response to pneumococcal vaccine, patients must discontinue treatment with H2-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapy
  • Unwilling or unable to participate in all required study evaluations and procedures
  • Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Seema A. Bhat, MD, Seema.bhat@osumc.edu

    Seema A. Bhat, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase II Comparative Study of Anti-Pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

This phase II trial compares the effect of initial vaccination (PCV20 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Current vaccination schedule for chronic lymphocytic leukemia patients is based on general recommendations in immunocompromised patients (initial vaccination with PCV13 followed by one dose of PSV23 after an interval of two months, followed by revaccination at 5 years). Giving patients frequent immunization as compared to 5 year immunization may result in higher protective titers in patients.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year) at 2 years (Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the enzyme-linked immunosorbent assay [ELISA] method).

SECONDARY OBJECTIVES:

  1. Number of patients with anti-pneumococcal immunogenicity at 5 years. II. Number of patients with local and/or general reaction at months 1, 3 as self-reported.

III. Number of pneumococcal infections.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive PCV 20 IM at week 0. Titers will be checked 4 weeks after this dose. Booster Vaccine: None. Titers will be checked at 12 weeks and then yearly for 5 years.

ARM B: Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: None. Annual titers will be checked for 5 years.

ARM C: Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: PCV23 booster vaccination dose will be administered yearly for 5 years. Pre-vaccination and post-vaccination (at 4 weeks) titers will be checked each time yearly for 5 years.

Being tested
Pneumococcal 20-valent Conjugate Vaccine, Pneumococcal Polyvalent Vaccine
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.

  • Pneumococcal 20-valent Conjugate VaccineBiological

    Also called PCV 20, PCV 20 Vaccine, Prevnar 20

    Given IM

  • Pneumococcal Polyvalent VaccineBiological

    Also called PCV 23, Pneumococcal 23-valent Polysaccharide Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Vaccine Polyvalent

    Given IM

Study groups in NCT05417165
Study groupRoleWhat they receive
Arm A (Standard ARM- No Booster)Active comparatorPatients receive PCV 20 IM at week 0. Titers will be checked 4 weeks after this dose. Booster Vaccine: None. Titers will be checked at 12 weeks and then yearly for 5 years.
Receives: Biological: Pneumococcal 20-valent Conjugate Vaccine
Arm B (Experimental ARM-No Booster)ExperimentalPatients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: None. Annual titers will be checked for 5 years.
Receives: Biological: Pneumococcal 20-valent Conjugate Vaccine; Biological: Pneumococcal Polyvalent Vaccine
Arm C (Experimental ARM-Annual Booster)ExperimentalPatients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: PCV23 booster vaccination dose will be administered yearly for 5 years. Pre-vaccination and post-vaccination (at 4 weeks) titers will be checked each time yearly for 5 years.
Receives: Biological: Pneumococcal 20-valent Conjugate Vaccine; Biological: Pneumococcal Polyvalent Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year)

    Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the enzyme-linked immunosorbent assay (ELISA) method.

    Measured: At 2 years

Secondary outcomes (3)

  1. Proportion of patients with anti-pneumococcal immunogenicity

    Measured: At 5 years

  2. Proportion of patients with local and/or general reaction

    Measured: At 1 and 3 months

  3. Number of pneumococcal infections

    Measured: At 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start29 Sep 2023
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05417165
Sponsor's protocol ID
OSU-21289
Other IDs
NCI-2022-01763
Status last verified
Jan 2026
First submitted
9 Jun 2022
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumococcal 20-valent Conjugate Vaccine and Pneumococcal Polyvalent Vaccine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Seema Bhat at 1 site in United States.

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 4 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year) (time frame: At 2 years). 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 NCT05417165, 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 7 Jan 2026.

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