drugset / Trial / NCT05417165

Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

NCT05417165

Phase 2 Recruiting 80 enrolled Seema Bhat
RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2023-09-29
Primary completion
2026-10-31
Completion
2026-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject PCV20 Vaccine Intramuscular
Subject Pneumovax 23 Vaccine Intramuscular