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Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases
Sponsor: University of Sao Paulo General Hospital
Summary
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.
Official title: Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases
Key Details
Gender
All
Age Range
2 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2026-01-16
Completion Date
2027-12-30
Last Updated
2026-03-04
Healthy Volunteers
Yes
Conditions
Interventions
Pneumococcal Vaccine
0.5 mL intramuscular dose containing polysaccharide conjugates for 20 pneumococcal serotypes (PCV20, Prevenar 20) vaccine will be administered intramuscularly in 1 dose in patients with ARDs and healthy controls.
Locations (1)
Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil