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Pneumonia Vaccines for CLL Patients (PROTECT CLL Trial)

This study is testing if two pneumonia vaccines, PCV20 and PPSV23, can create a strong immune response in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These vaccines protect against bacteria that cause pneumonia. Researchers want to see if giving these vaccines together helps prevent infections in CLL patients. To join, you must be at least 18 years old, have a confirmed diagnosis of CLL or SLL, and not have received prior treatment for your condition. The study will measure how well your body makes antibodies after vaccination. The current recruitment status is unclear.

Study design
This is a Phase II interventional study planning to enroll 61 participants. It is a single-center trial.
What's involved
Participants will receive PCV20 and PPSV23 vaccines. Blood tests will be done at 30 and 90 days after PCV20 vaccination to measure antibody levels.
Compensation
Not stated in the trial record.
Follow-up
Antibody levels will be measured up to 90 days after PCV20 vaccination.

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NCT05183854

Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Utah
~61 participants
Updated 2026-04-09 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 who achieve the protocol defined change in antibody titers
Measured over At 30 and 90 days post-PCV20 vaccination

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
Utah1

Study leadership

  • Daniel Ermann, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

David Samuel
[email protected]
801-587-4713
Email the study team

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Eligibility criteria

Inclusion

NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
NAIVE COHORT: Male or female subject aged \>= 18 years.
NAIVE COHORT: Subjects must not have received prior therapy for CLL.
VENETOCLAX-TREATMENT COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =\< 12 months prior to registration.

Exclusion

Subjects who have experienced a severe allergic reaction to prior pneumococcal vaccination.
Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the last five years.
If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they may be included.
Active infection requiring systemic antibiotic therapy.
Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:
Intranasal, inhaled, topical steroids, eye drops or local steroid injection (e.g., intra-articular injection);
Systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent;
Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication).
Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.

What this trial measures

  • Proportion of patients who achieve the protocol defined change in antibody titersAt 30 and 90 days post-PCV20 vaccination

    Will examine the proportion of patients who achieve the protocol defined change in antibody titers from baseline in at least 10 of 19 S.pneumoniae serotypes shared between pneumococcal 20-valent conjugate vaccine (PCV20) and pneumococcal polyvalent vaccine (PPSV23) at Study Visit 2 and 3. The observed proportion and an exact 95% binomial confidence interval will be reported. A one sample exact binomial test will be performed at one-sided alpha = 0.05. The null hypothesis is that the proportion is 50% or lower.