Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Seroconversion Rate After Vaccination — Day 0 to Day 28 and through 180 days
Will be defined as ≥2-fold increase in IgG titers for ≥50% of serotypes.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | São Paulo | Recruiting |
More University of Sao Paulo General Hospital trials in Brazil
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07252791 on ClinicalTrials.gov ↗ ← All trials in Brazil