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

NCT05183854 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HCI145280NCI-2021-13373
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  At 30 and 90 days post-PCV20 vaccination

Secondary Outcomes (4)

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

  Up to 5 years post- PPSV23 vaccination

• 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

  Up to 5 years post PPSV23 vaccination

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

  At 30 and 90 days post-PCV20 vaccination

• Proportion of patients who maintain adequate immune response

  Up to 5 years post PPSV23 vaccination

Other Outcomes (2)

• Number of patients that contract pneumonia

  Up to 5 years post PPSV23 vaccination

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

  At 30 and 90 days post PCV20 vaccination

Study Arms (2)

Arm I (PCV20, PPSV23)

EXPERIMENTAL

Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)

Biological: Pneumococcal 20-valent Conjugate Vaccine; Biological: Pneumococcal Polyvalent Vaccine

Arm II (PCV20, PPPSV23)

EXPERIMENTAL

Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity.

Biological: Pneumococcal 20-valent Conjugate Vaccine; Biological: Pneumococcal Polyvalent Vaccine

Interventions

Pneumococcal Polyvalent Vaccine BIOLOGICAL

Given IM

Also known as: PCV 23, Pneumococcal 23-valent Polysaccharide Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Vaccine Polyvalent, Pneumovax 23, Pnu-Imune 23, PPSV, PPSV23, PPSV23 Vaccine

Arm I (PCV20, PPSV23); Arm II (PCV20, PPPSV23)

Pneumococcal 20-valent Conjugate Vaccine BIOLOGICAL

Given IM

Also known as: PCV 20, PCV 20 Vaccine, Prevnar 20

Arm I (PCV20, PPSV23); Arm II (PCV20, PPPSV23)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (20)

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  BACKGROUND

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MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Pneumococcal Vaccines; 23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Daniel Ermann, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Samuel

CONTACT

801-587-4713; david.samuel@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: January 31, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)