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Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases

Study acronym: PCV20-PARD
StatusRecruiting
PhasePhase 4
Started2026-01-16
View on ClinicalTrials.gov ↗

Amendment history

2026-03-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-01→confirmed 2026-01-16
Study sites0→1
2025-11-18
Original filing
This clinical trial evaluates the immunogenicity (humoral and cellular) and safety of the 20-valent pneumococcal conjugate vaccine (PCV20) in children, adolescents, and young adults aged 2-25 years with autoimmune rheumatic diseases (ARDs). All participants will receive PCV20 according to prior vaccine history. Antibody titers, opsonophagocytic activity, cellular immune responses, and adverse events will be measured up to 6 months post-vaccination. Effects of immunosuppressive therapy and physical activity levels related vaccine response will also be assessed.
Trial Details
NCT Number NCT07252791
Lead Sponsor University of Sao Paulo General Hospital
Collaborators: Instituto Adolfo Lutz
Conditions Autoimmune Rheumatologic Disease
Enrollment 114 participants
Start Date 2026-01-16
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-04