Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Seroconversion Rate After Vaccination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2-25 years
- •Diagnosis of JIA, jSLE, or JDM by validated classification criteria
- •Clinically stable
- •Informed consent/assent
排除标准
- •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
研究组 & 干预措施
ARDs
PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
干预措施: Pneumococcal Vaccine (Biological)
Healthy control
PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
干预措施: Pneumococcal Vaccine (Biological)
结局指标
主要结局
Seroconversion Rate After Vaccination
时间窗: Day 0 to Day 28 and through 180 days
Will be defined as ≥2-fold increase in IgG titers for ≥50% of serotypes.
次要结局
- Opsonophagocytic Antibody Titers (OPA)(Day 0 to Day 28 and through 180 days)
- Safety Assessment(Day 1 through Day 28)
- Impact of PCV20 vaccination on Disease Activity on patients with JIA(Day 1 through Day 28)
- Impact of PCV20 vaccination on Disease Activity on patients with JSLE(Day 1 through Day 28)
- Impact of PCV20 vaccination on Disease Activity on patients with JDM(Day 1 through Day 28)
- Influence of Immunosuppressive Treatment(Day 0 to Day 180)
- Seroconversion Rates after PCV20 vaccination by Physical Activity Classification(Day 1 to 180 post-vaccination)
- Geometric Mean Titers of Pneumococcal Antibodies after PCV20 Vaccination by Physical Activity Classification(Day 1 to 180 post-vaccination)