Autoimmune Rheumatologic Disease
Conditions
Keywords
Pneumococcal Conjugate Vaccine, PCV20, Autoimmune Diseases, Pediatric Rheumatology, Immunogenicity, Vaccine Safety
Brief 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.
Detailed description
ARD patients are at higher risk of pneumococcal infections due to disease-related and therapy-induced immunosuppression. Despite vaccination recommendations, immunogenicity data for PCV20 in ARD pediatric populations are lacking. This prospective phase IV study will enroll 85 patients aged 2-25 years diagnosed with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (jSLE), and juvenile dermatomyositis (JDM). All will receive PCV20 per CDC guidance. Blood samples will be collected at baseline (D0), 4 weeks (D28), and 6 months (D180). The functional opsonophagocytic activity (OPA) for specific serotypes will be analyzed. Safety will be monitored through adverse event diaries, clinical evaluations, and disease activity indices. Physical activity will be evaluated by validated questionnaires and via accelerometry.
Interventions
BIOLOGICALPneumococcal Vaccine
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.
Sponsors
University of Sao Paulo General Hospital
Insituto Adolfo Lutz
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 2-25 years * Diagnosis of JIA, jSLE, or JDM by validated classification criteria * Clinically stable * Informed consent/assent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Rate After Vaccination | Day 0 to Day 28 and through 180 days | Will be defined as ≥2-fold increase in IgG titers for ≥50% of serotypes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opsonophagocytic Antibody Titers (OPA) | Day 0 to Day 28 and through 180 days | 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 | Day 1 through Day 28 | 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 | Day 1 through Day 28 | 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 | Day 1 through Day 28 | 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) |
| Impact of PCV20 vaccination on Disease Activity on patients with JDM | Day 1 through Day 28 | To evaluate the impact of PCV20 vaccination on clinical and laboratory disease activity in patients with juvenile dermatomyositis (JDM), assessed using the Childhood Myositis Assessment Scale (CMAS). The CMAS evaluates muscle function and endurance, with higher scores indicating better muscle strength and physical performance. Unit of Measure: Score (range 0-52) |
| Influence of Immunosuppressive Treatment | Day 0 to Day 180 | To assess the short- and long-term influence of immunosuppressive treatment on the response to PCV-20 vaccination in patients with ARDs compared to healthy controls. |
| Seroconversion Rates after PCV20 vaccination by Physical Activity Classification | Day 1 to 180 post-vaccination | Proportion of participants who achieve seroconversion defined as at least a twofold increase in pneumococcal serotype-specific IgG antibody concentrations compared to baseline at Days 28 and 180 following PCV20 vaccination. Participants will be categorized as physically active or inactive based on World Health Organization criteria using validated methods. |
| Geometric Mean Titers of Pneumococcal Antibodies after PCV20 Vaccination by Physical Activity Classification | Day 1 to 180 post-vaccination | Geometric mean titers of pneumococcal serotype-specific IgG antibodies will be quantified using multiplex Luminex assay at Days 28 and 180 after PCV20 vaccination. Participants will be classified as physically active or inactive according to the World Health Organization criteria, based on validated methods. |
Countries
Brazil
Contacts
CONTACTClovis A Silva, Full Professor
Outcome results
None listed