Actively Recruiting
Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases
Led by University of Sao Paulo General Hospital · Updated on 2026-03-04
114
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
I
Insituto Adolfo Lutz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 25 years
- Diagnosed with juvenile idiopathic arthritis, juvenile systemic lupus erythematosus, or juvenile dermatomyositis using validated criteria
- Clinically stable condition
- Provided informed consent or assent
You will not qualify if you...
- Acute infection or fever at the time of vaccination
- Severe allergic reaction to any vaccine components
- Blood transfusion within the last 6 months
- Received another vaccine within 4 weeks before study inclusion
- Pregnant or breastfeeding
- Previously received the PCV20 vaccine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Actively Recruiting
Research Team
C
Clovis A Silva, Full Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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