Recruiting
Phase 2

Vaccine with CLL

Sponsor:

Seema Bhat

Code:

NCT05417165

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pneumococcal 20-valent Conjugate Vaccine

Pneumococcal Polyvalent Vaccine

Study Details

Brief 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. 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.

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Study ID

NCT05417165

Start date

Sep 29, 2023

Status verified date

Jan, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Arm A (Standard ARM- No Booster)

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.

experimental: Arm B (Experimental ARM-No Booster)

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.

experimental: Arm C (Experimental ARM-Annual Booster)

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.

Interventions

Pneumococcal 20-valent Conjugate Vaccine

Given IM

Pneumococcal Polyvalent Vaccine

Given IM

Primary outcome measure

  • Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year) [ Time Frame: At 2 years ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Seema A. Bhat, MD

Seema.bhat@osumc.edu

Principal Investigator:

Seema A. Bhat, MD

More Information

Sponsor

Seema Bhat

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Seema Bhat on 2026-01-07.