NCT05417165 · Seema Bhat
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Pneumococcal 20-valent Conjugate Vaccine
Given IM
BIOLOGICAL
Pneumococcal Polyvalent Vaccine
Given IM
Primary outcome measures
Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations