Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Seema Bhat
Study ID
NCT05417165
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 compares the effect of initial vaccination (PCV20 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Current vaccination schedule for chronic lymphocytic leukemia patients is based on general recommendations in immunocompromised patients (initial vaccination with PCV13 followed by one dose of PSV23 after an interval of two months, followed by revaccination at 5 years). Giving patients frequent immunization as compared to 5 year immunization may result in higher protective titers in patients.

Key Dates

Start date
Sep 29, 2023
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm A (Standard ARM- No Booster)
    Patients receive PCV 20 IM at week 0. Titers will be checked 4 weeks after this dose. Booster Vaccine: None. Titers will be checked at 12 weeks and then yearly for 5 years.
  • Experimental: Arm B (Experimental ARM-No Booster)
    Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: None. Annual titers will be checked for 5 years.
  • Experimental: Arm C (Experimental ARM-Annual Booster)
    Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: PCV23 booster vaccination dose will be administered yearly for 5 years. Pre-vaccination and post-vaccination (at 4 weeks) titers will be checked each time yearly for 5 years.

Primary Outcome Measure

Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year) [ Time Frame: At 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Seema A. Bhat, MD
[email protected]
Seema A. Bhat, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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