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

RecruitingPhase 4Ages 2 Years - 25 YearsAllUniversity of Sao Paulo General Hospital
NCT07252791 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 2-25 years * Diagnosis of JIA, jSLE, or JDM by validated classification criteria * Clinically stable * Informed consent/assent Exclusion Criteria: * 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
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What it tests

  • Pneumococcal Vaccine
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Where

1 site
Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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