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.
Age 2-25 years
Diagnosis of JIA, jSLE, or JDM by validated classification criteria
Clinically stable
Informed consent/assent
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
Parallel
Pneumococcal Vaccine
Biological/Vaccine0.5 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.
Seroconversion Rate After Vaccination
Will be defined as ≥2-fold increase in IgG titers for ≥50% of serotypes.
Opsonophagocytic Antibody Titers (OPA)
Blood samples will be collected at three time points: before the first dose (D0), 4 weeks after the first dose (D28), and six months after the final dose (D180). Functional opsonophagocytic anticapsular antibodies will be quantified using 6 validated serotype-specific opsonophagocytic activity (OPA) assays. Results will be expressed as geometric mean titers (GMTs) for each serotype and the percentage of participants reaching titers equal to or above the lower limit of quantification (LLOQ).
Safety Assessment
Safety will be closely monitored, and all serious adverse events will be classified as related or unrelated to the vaccine. A standardized adverse event diary will be provided to all patients and healthy controls for recording local and systemic reactions during the 4 weeks after first dose. Local reactions include: injection site pain, redness, swelling, bruising, itching, and induration. Systemic reactions include: fever, fatigue, chills, malaise, drowsiness, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, dizziness, tremors, headache, fatigue, myalgia, muscle weakness, arthralgia, pruritus, and skin rash.
Impact of PCV20 vaccination on Disease Activity on patients with JIA
To evaluate the impact of PCV20 vaccination on clinical disease activity in patients with JIA, measured using JADAS27, higher scores indicate greater disease activity. Unit of Measure: Score (0-57)
Impact of PCV20 vaccination on Disease Activity on patients with JSLE
To evaluate the impact of PCV20 vaccination on clinical and laboratory disease activity in patients with juvenile systemic lupus erythematosus (jSLE), assessed using the SLEDAI-2K. The score incorporates clinical and laboratory manifestations of lupus, with higher scores indicating greater disease activity. Unit of Measure: Score (range 0-105)
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University of Sao Paulo General Hospital
Lead sponsor
Insituto Adolfo Lutz
Collaborator
