Recruiting
Phase 2

PCV20 & PPSV23

Sponsor:

University of Utah

Code:

NCT05183854

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 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

Study ID

NCT05183854

Start date

Jan 31, 2022

Status verified date

Apr, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

61 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (PCV20, PPSV23)

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)

experimental: Arm II (PCV20, PPPSV23)

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.

Interventions

Pneumococcal 20-valent Conjugate Vaccine

Given IM

Pneumococcal Polyvalent Vaccine

Given IM

Primary outcome measure

  • Proportion of patients who achieve the protocol defined change in antibody titers [ Time Frame: At 30 and 90 days post-PCV20 vaccination ]

Central Contacts and Locations

Central contacts

David Samuel

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

Locations

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Catherine Cromar

801-213-5652catherine.cromar@hci.utah.edu

Lindsey Gilstrap

801-213-5652lindsey.gilstrap@hci.utah.edu

Principal Investigator:

Daniel Ermann, MD

More Information

Sponsor

University of Utah

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Utah on 2026-04-09.