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

Recruiting now · Phase 4

Conditions studied: Autoimmune Rheumatologic Disease

In brief

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.

Key facts

Study ID

NCT07252791

Run by

University of Sao Paulo General Hospital

People needed

114

Starts

2026-01-16

Expected to finish

2027-12-30

Last updated by the study team

2026-03-04

Who can join

Age: 2 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 2-25 years
• Diagnosis of JIA, jSLE, or JDM by validated classification criteria
• Clinically stable
• Informed consent/assent

You may not qualify if…

• Acute infection or fever at vaccination
• Severe allergic reaction to vaccine components
• Recent blood transfusion (<6 months)
• Other vaccine within 4 weeks prior at the time of inclusion
• Pregnancy or breastfeeding
• Prior PCV20

Where it is running

• Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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