About this trial
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 criteria
Qualifiers
Age 2-25 years
Diagnosis of JIA, jSLE, or JDM by validated classification criteria
Clinically stable
Informed consent/assent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pneumococcal Vaccine
Treatment groups
Sponsors and collaborators
University of Sao Paulo General Hospital
Lead sponsor
Insituto Adolfo Lutz
Collaborator