RecruitingPhase 2NCT05183854

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

Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)


Sponsor

University of Utah

Enrollment

61 participants

Start Date

Jan 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV20 and PPSV23 are both vaccines that protect against bacteria that cause pneumococcal disease. Giving these vaccinations as series may make a stronger immune response and prevent against pneumococcal infections in patients with chronic lymphocytic leukemia. This is a single-center trial, conducted at Huntsman Cancer Institute.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the most effective pneumococcal vaccination strategy (against a common type of pneumonia) for patients with chronic lymphocytic leukemia (CLL) — a blood cancer that weakens the immune system — both in newly diagnosed untreated patients and in those who have been treated with venetoclax. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with CLL or small lymphocytic lymphoma (SLL) - Either: you have never received treatment for CLL (naive cohort), or you have been on venetoclax treatment for at least 12 months and your last dose was within the past 12 months (venetoclax cohort) **You may NOT be eligible if:** - You have had a severe allergic reaction to a previous pneumococcal vaccine - You received a pneumococcal vaccine (PCV13 or PCV20) in the past 5 years - You have an active infection requiring antibiotics - You are currently on immunosuppressive medications (other than low-dose steroids or inhaled/topical steroids) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPneumococcal 20-valent Conjugate Vaccine

Given IM

BIOLOGICALPneumococcal Polyvalent Vaccine

Given IM


Locations(1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

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NCT05183854


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