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NCT Number: NCT05183854

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Pneumococcal 20-valent Conjugate Vaccine

Biological

Given IM

Other names: PCV 20, PCV 20 Vaccine, Prevnar 20

pneumococcal polyvalent vaccine

Biological

Given IM

Other names: PCV 23, Pneumococcal 23-valent Polysaccharide Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Vaccine Polyvalent, Pneumovax 23, Pnu-Imune 23, PPSV, PPSV23, PPSV23 Vaccine

Primary outcomes

  1. Proportion of patients who achieve the protocol defined change in antibody titers

    Time frame: At 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.

Secondary outcomes

  1. Proportion of patients who have a two-fold increase of immunoglobulin levels

    Time frame: Up to 5 years post- PPSV23 vaccination

    Will examine the proportion of patients who have a two-fold increase of immunoglobulin levels from baseline at Study Visit 2 and 3 and do not develop pneumonia within five years post-PPSV23 vaccination. The observed proportion and an exact 95% binomial confidence interval will be reported.

  2. Proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines

    Time frame: Up to 5 years post PPSV23 vaccination

    Will examine the proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines and do not develop pneumonia within five years post PPSV23 vaccination. The observed proportion and an exact 95% binomial confidence interval will be reported.

  3. Proportion of patients who have a two-fold increase in antibody titers to an individual serotype vaccination

    Time frame: At 30 and 90 days post-PCV20 vaccination

    Will examine the proportion of patients who have a two-fold increase in antibody titers to an individual serotype at Study Visit 2 and 3 post PPCV20 vaccination. The observed proportion and 95% exact binomial confidence intervals will be reported for each serotype.

  4. Proportion of patients who maintain adequate immune response

    Time frame: Up to 5 years post PPSV23 vaccination

    Will examine the proportion of patients who maintain adequate immune response, defined as two-fold increase in antibody titers from baseline in 10/19 of S. pneumoniae serotypes, from PPSV23 vaccination to time of last follow-up at 5 years. Kaplan-Meier methods will be used to analyze time-to-pneumonia from baseline until five years after PPSV23 vaccination.

Other outcomes

  1. Number of patients that contract pneumonia

    Time frame: Up to 5 years post PPSV23 vaccination

    Kaplan-Meier methods will be used to analyze time-to-pneumonia from baseline until five years after study entry, stratified by therapeutic strategy.

  2. Proportion of venetoclax treated chronic lymphocytic leukemia (CLL) patients who achieve a two-fold increase in antibody titers

    Time frame: At 30 and 90 days post PCV20 vaccination

    Will examine the proportion of Venetoclax treated CLL patients who achieve a two-fold increase in antibody titers from baseline in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines at Study Visit 2 and 3.

Study contacts

Contact information is provided by the study sponsor or research team.

David Samuel

CONTACT

[email protected]

801-587-4713

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jan 11, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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