Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis: a Pilot Study Following New Vaccine Recommendations. PneumoVas Pilot 2
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anti-pneumococcal immunity after combined anti-pneumococcal immunization
研究概览
简要总结
Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks later).
详细描述
The purpose of this study is to determine whether this vaccination schedule induces sufficient protective immunity (serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) response rates) in AAV-patients receiving immunosuppressive therapy.
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
- •ANCA-associated vasculitis: diagnosis of granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
- •Indication for pneumococcal vaccination according to French recommendations (statement of the Haut Conseil de Santé Publique regarding pneumococcal vaccination for adults and children older than 2 years old at risk for invasive pneumococcal disease, April 25Th 2013)
排除标准
- •History of pneumococcal immunization 36 months to 24hours before VO.
- •Patients with known, or suspected pregnancy
- •Patients planning to get pregnant in the year following inclusion
- •Splenectomy
- •Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss) flare
- •Infection during the week before inclusion
- •Patient without social security coverage
- •Individuals opposal
结局指标
主要结局
Anti-pneumococcal immunity after combined anti-pneumococcal immunization
时间窗: visit V1 (12 to 16 weeks after V0 (Day 0))
Proportion of responder patients at V1 (12-weeks after PCV13 injection) 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 PCV13 and PPV23. A serotype is considered positive if the ELISA immunoglobulins G (IgG) antibody titter shows a two-fold increase from baseline (V0) to V1 and is ≥ 1 μg/ml
次要结局
- To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F-specific immune responses after vaccination(visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).)
- Change Outcome Measures-To assess the sustainability and evolution over time of the vaccine-induced immune response (ELISA and OPA)(visit V2 (48 to 56 weeks after V0).)
- To assess serotype coverage increase after PPV23 injection(visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).)
- Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.(visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).)
- For the following serotypes (4, 6B, 9V, 14, 18C, 19F and 23F), to assess the proportion of ELISA-responding patients who also show in vitro opsonophagocytic antibody activity.(visit V0 (Day 0), visit V1(12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).)