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Anti-Pneumococcal Vaccine Strategy for CLL and SLL

This study is looking at better ways to protect people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) from pneumococcal infections. These conditions can make vaccines less effective. The study compares giving you the Pneumococcal 20-valent Conjugate Vaccine (BIOLOGICAL) and Pneumococcal Polyvalent Vaccine (BIOLOGICAL) with yearly booster shots, versus the current standard vaccination schedule. Researchers want to see if more frequent vaccinations lead to stronger protection against these infections over two years. You may be able to join if you are 18 or older, have CLL or SLL, and have not received prior treatment for your condition.

Study design
This interventional study plans to enroll 80 participants and randomly assigns them to one of three groups to compare different vaccination schedules.
What's involved
You would receive initial vaccinations, have blood tests to check your immune response at specific times, and potentially receive yearly booster vaccinations for up to five years.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured at 2 years, and yearly for 5 years in some groups.

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NCT05417165

Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Recruiting
PHASE2Ages 18+InterventionalPrevention
Seema Bhat
~80 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Pneumococcal 20-valent Conjugate VaccinePneumococcal Polyvalent Vaccine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year)
Measured over At 2 years

Conditions

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Seema A Bhat, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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)

What this trial measures

  • 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.