Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 14
- 主要终点
- number of patients with anti-pneumococcal immunogenicity
研究概览
简要总结
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.
Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who have given their written consent in a free and informed consent
- •Patient followed for inflammatory bowel disease (Crohn's disease, ulcerative colitis or indeterminate colitis), and treated for at least 3 months by immunosuppressive therapy and /or biotherapies and in clinical remission for at least 3 months
- •Patient agreeing to participate in the study throughout its duration and accepting the procedures related to the study
- •Contraception that the investigator judges effective for the first 12 months of the trial, with a negative pregnancy test
- •Women not planning to become pregnant in the 12 months following inclusion (M0)
- •Patient with social coverage
排除标准
- •Patients vaccinated against pneumo23 for less than 5 years
- •Other vaccination during the month before inclusion
- •Patient develops a febrile illness (at least 37 ° C 5 measured orally) or acute infection in the week before vaccination
- •The patient has a flare up of IBD the day of vaccination (Harvey-Brasdshaw score of at least 6 or CDAI > 220 for Crohn's disease or Mayo Clinic score of at least 4 for UC and indeterminate colitis)
- •Patients with an ongoing pregnancy the day of vaccination
- •Patient with a known history of neuropathy as Guillain-Barré syndrome.
- •Patients with known infection with HIV and / or HBV (HBsAg positive) and / or HCV
- •Patient with other severe immune deficiency
- •Patients who received immunoglobulin infusions of blood products, or of monoclonal antibodies (except anti-TNF) in the 3 months prior to vaccination
- •Patient institutionalized, or deprived of liberty administrative or judicial
- •Patients treated without immunosuppressive therapy or biotherapies
结局指标
主要结局
number of patients with anti-pneumococcal immunogenicity
时间窗: month 5
Measured the serologies against serotypes to Prevenar 13. Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the ELISA method
次要结局
- Number of patients with local and/or general reaction(Months 1, 3 and 5)
- Number of patients with inflammatory disease activity(Months 1, 3, 4, 5, 12, 18, 36)
- Factors implicated in anti-pneumococcal vaccination efficacy(Month 0)
- number of patients with serotype coverage of PSV-23(Months 5, 12, 18 and 36)