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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05183854
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pneumococcal 20-valent Conjugate Vaccine — BIOLOGICAL
    Given IM
  • Pneumococcal Polyvalent Vaccine — BIOLOGICAL
    Given IM

Study Details

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.

Key Dates

Start date
Jan 31, 2022
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
61 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Catherine Cromar
[email protected]
801-213-5652
Lindsey Gilstrap
[email protected]
801-213-5652
Daniel Ermann, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Huntsman Cancer Institute/University of Utah· Salt Lake City, UT

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