Randomised, Multicentric, Phase ii Study of the Immunogenicity of a "Prime Boost" Vaccination Strategy Combining Conjugated Anti- Pneumococcal Vaccine (s0) and Polysaccharide Anti- Pneumococcal Vaccine (s4) Compared to Polysaccharide Anti- Pneumococcal Vaccine Alone (s4) In Patients With Common Variable Immunodeficiency
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- proportion of responders to each serotype
研究概览
简要总结
The main objective of this study is to evaluate and to compare the specific antibody response to a " prime-boost " vaccine strategy combining the seven valence pneumococcal conjugate vaccine (PnCj) prime at W0 followed by the administration of the pneumococcal capsular polysaccharide vaccine (PPS) boost at W4, to the administration of the pneumococcal capsular polysaccharide vaccine (PPS) alone at W4 in patients with common variable immunodeficiency.
详细描述
Main objective :
The main objective of this study is to evaluate and to compare the specific antibody response to a " prime-boost " vaccine strategy combining the seven valence pneumococcal conjugate vaccine (PnCj) prime at W0 followed by the administration of the pneumococcal capsular polysaccharide vaccine (PPS) boost at W4, to the administration of the pneumococcal capsular polysaccharide vaccine (PPS) alone at W4 in patients with common variable immunodeficiency.
Secondary objectives :
- Evaluation and comparison the specific antibody response to seven pneumococcal serotypes, shared by the PnCj and PPS vaccines (4, 6B, 9V, 14, 18C, 19F, 23F), and two serotypes of the PPS vaccine (1, 5) 4 weeks after the single (W8 for patients from Group 1) or the first vaccination (W4 for patients from group 2).
- Evaluation of the duration of the specific antibody response at week 24
- Evaluation of the T CD4 lymphocyte response (proliferation and cytokine production) to the CRM protein
- Study of the Immunoglobulin V gene repertoire (immunoscope) before and after vaccination.
- Safety of the vaccines
- Effect of the vaccine strategies on the frequency of Streptococcus pneumoniae infections (bronchitis, sinusitis and recurrent upper respiratory tract)
EXPERIMENTAL METHODS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 65 years
- •Common variable immunodeficiency according to the WHO criteria,
- •Patients treated with intravenous or subcutaneous immunoglobulin.
- •Written informed consent
- •Absence of acute infections, or other evolutive diseases related to the (cancer, auto-immune disease...)
排除标准
- •IgG subclass deficiency
- •IgA selective deficiency,
- •Other primary humoral deficiency (X-linked agammaglobulinemia, Hyper IgM syndrome),
- •Long course treatment with corticosteroids > 5mg per day
- •Chemotherapy in the last 3 years,
- •Prior pneumococcal vaccination in the last 2 years.
结局指标
主要结局
proportion of responders to each serotype
时间窗: 8 weeks
The primary end point of this study is the proportion of responders to each serotype contained in the PnjC vaccine in the two groups of this study according to 4 categories: 5-7; 3-4; 2-1 and 0. A responder is defined by a rise (at least two fold from baseline) of antibody titers specific to pneumococcal serotypes.
次要结局
未报告次要终点