Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-25
SponsorUniversity of Sao Paulo General Hospital

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

114 Participants
are divided into 2 treatment groups

Sponsors and collaborators