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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Jun 2026 to Mar 2027 Enrollment target: 60 to 61 · Interventions: Pneumococcal 20-valent Conjugate Vaccine (Biological), Pneumococcal Polyvalent Vaccine (Biological), Questionnaire Administration (Other) to Pneumococcal 20-valent Conjugate Vaccine (Biological), Pneumococcal Polyvalent Vaccine (Biological) · Study description shortened, about 281 words · 2 morev10 Show 5 more changesShow less
    • Enrollment target: 60 to 61
    • Interventions: Pneumococcal 20-valent Conjugate Vaccine (Biological), Pneumococcal Polyvalent Vaccine (Biological), Questionnaire Administration (Other) to Pneumococcal 20-valent Conjugate Vaccine (Biological), Pneumococcal Polyvalent Vaccine (Biological)
    • Study description shortened, about 281 words
    • Site contact updated
    • Collaborators shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jan 7, 2026 to Jun 2026 Completion date: Jan 7, 2028 to Jun 2028v9 Show 1 more changeShow less
    • Completion date: Jan 7, 2028 to Jun 2028
  3. Primary completion date: Jan 7, 2025 to Jan 7, 2026 Completion date: Jan 7, 2027 to Jan 7, 2028v8 Show 1 more changeShow less
    • Completion date: Jan 7, 2027 to Jan 7, 2028
  4. Start date: Jan 7, 2022 to Jan 31, 2022v7
  5. Secondary endpoints revised (4) Site contact updatedv6 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Interventions: Pneumococcal 13-valent Conjugate Vaccine (Biological), Pneumococcal Polyvalent Vaccine (Biological), Questionnaire Administration (Other) to Pneumococcal 20-valent Conjugate Vaccine (Biological), Pneumococcal Polyvalent Vaccine (Biological), Questionnaire Administration (Other) Eligibility criteria expanded, about 20 words · Secondary endpoints revised (4) · Study description revised · 1 morev5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (4)
    • Study description revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv4
  3. Eligibility criteria expanded, about 2 wordsv3 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Site details revisedv2 Show 2 more changesShow less
    • Primary endpoint revised
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05183854
Lead Sponsor University of Utah
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov