Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 25
Healthy Volunteers: t
View:
• Age 2-25 years
• Diagnosis of JIA, jSLE, or JDM by validated classification criteria
• Clinically stable
• Informed consent/assent
Locations
Other Locations
Brazil
Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Clovis A Silva, Full Professor
reumatologia.fmusp@hc.fm.usp.br
(11) 2661-6105
Time Frame
Start Date: 2026-01-16
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 114
Treatments
Experimental: ARDs
PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Active_comparator: Healthy control
PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital
Collaborators: Insituto Adolfo Lutz