Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases
Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases
University of Sao Paulo General Hospital
114 participants
Jan 16, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Age 2-25 years
- Diagnosis of JIA, jSLE, or JDM by validated classification criteria
- Clinically stable
- Informed consent/assent
Exclusion Criteria6
- 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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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07252791