Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis. PneumoVas Pilot 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Residual anti-pneumococcal immunity after pneumococcal immunization.
研究概览
简要总结
Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through pneumococcal immunization.
详细描述
The purpose of this study is to determine, through serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) titres whether AAV patients who have gone through pneumococcal vaccination are protected against invasive pneumococcal diseases (IPD).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: diagnosis for granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
- •Anti-pneumococcal immunization in the past 36 months
- •History of anti-pneumococcal vaccination according to French recommendations (simple vaccine schedule with PPV23 or combine vaccine schedule with PCV13 followed by PPV23 8 weeks later)
排除标准
- •Known or suspected pregnancy
- •Splenectomy
- •Patient without social security coverage
- •Patient opposal
结局指标
主要结局
Residual anti-pneumococcal immunity after pneumococcal immunization.
时间窗: visit V0 (day 0)
Proportion of patients at baseline (V0) with ≥1 µg/mL ELISA immunoglobulins G (IgG) antibody titers to at least 6 of the 10 shared serotypes (i.e. 3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) included both in the 13-valent conjugate pneumococcal vaccine (PCV13) and in the 23-valent non-conjugate pneumococcal vaccine (PPV23)
次要结局
- To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F, 23F, 10A and 12F-specific residual immunity after vaccination(visit V0 (day 0), visit V-1 (pre immunization))
- For each of the following serotypes (3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), to assess among ELISA-protected patients (i.e. with a ≥1 µg/mL ELISA IgG antibody titer) the proportion who also show in vitro opsonophagocytic antibody activity(visit V0 (day 0))
- For patients for whom pre-vaccinal serum is available (via the PHENOVASC bank), to assess the impact of immunization on serotype-specific ELISA antibody titer and OPA activity.(visit V-1 (pre immunization) ; visit V0 (day 0))
- Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.(visit V-1 (pre immunization) ; visit V0 (day 0))