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首页> 外文期刊>Proceedings of the National Academy of Sciences of the United States of America >A double-blind randomized placebo-controlled phase Ⅲ study of a Pseudomonas aeruginosa flagella vaccine in cystic fibrosis patients
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A double-blind randomized placebo-controlled phase Ⅲ study of a Pseudomonas aeruginosa flagella vaccine in cystic fibrosis patients

机译：铜绿假单胞菌鞭毛疫苗在囊性纤维化患者中的双盲随机安慰剂对照Ⅲ期研究

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Pseudomonas aeruginosa causes life-threatening lung infections in patients with cystic fibrosis. We hypothesized that vaccination may prevent P. aeruginosa lung infection. In a double-blind, placebo-controlled, multicenter trial, 483 European patients, 2-18 years of age without P. aeruginosa colonization were randomly assigned to receive four intramuscular injections of a bivalent P. aeruginosa flagella vaccine or placebo over a 14-month period. Patients were evaluated quarterly for P. aeruginosa-positive throat cultures and antipseudomonal serum antibody titers during the study period of 2 years. The vaccine was well tolerated, and the patients developed high and long-lasting serum antif lagella IgG titers. In the intention-to-treat group (all patients enrolled), 82 of 239 vaccinated patients had P. aeruginosa infection and/or antipseudomonal serum titers compared with 105 of 244 patients in the placebo group (P = 0.05; relative risk: 0.80; 95% Cl: 0.64-1.00). Analysis of the 381 patients in the per-protocol group, who received all four vaccinations or placebo treatments, revealed 37 of 189 patients with infection episodes in the vaccine group compared with 59 of 192 patients with such episodes in the placebo group (P = 0.02; relative risk: 0.66; 95% Cl: 0.46-0.93). P. aeruginosa strains, exhibiting flagella subtypes included in the vaccine, were significantly less frequently isolated from vaccinates than from placebo controls (P = 0.016, relative risk: 0.319; 95% Cl: 0.12-0.86). Chronic P. aeruginosa infection was rare because of recent institution of early antibiotic eradication regimes. Active immunization of patients with cystic fibrosis lowers the risk for infection with P. aeruginosa and therefore may contribute to a longer survival of these patients.
机译：铜绿假单胞菌在囊性纤维化患者中引起威胁生命的肺部感染。我们假设疫苗接种可以预防铜绿假单胞菌肺部感染。在一项双盲，安慰剂对照，多中心试验中，随机分配了483名2-18岁无铜绿假单胞菌定植的欧洲患者，接受了14剂铜绿假单胞菌鞭毛二价疫苗或安慰剂的肌肉注射。一个月期间。在为期2年的研究期内，每季度对患者进行铜绿假单胞菌阳性喉培养和抗假性血清抗体滴度评估。疫苗耐受性好，患者出现了高而持久的血清抗纤毛虫IgG滴度。在意向治疗组（所有入组患者）中，239例接种疫苗的患者中有82例出现了铜绿假单胞菌感染和/或抗假性血清滴度，而安慰剂组的244例患者中有105例（P = 0.05；相对危险度：0.80；对照组）。 95％Cl：0.64-1.00）。对按方案分组的381名患者进行了全部四种疫苗接种或安慰剂治疗的分析显示，疫苗组中189名感染发作的患者中有37名患者，而安慰剂组192名此类发作的患者中有59名（P = 0.02） ；相对风险：0.66； 95％Cl：0.46-0.93）。与疫苗安慰剂对照相比，从疫苗中分离出具有疫苗中鞭毛亚型的铜绿假单胞菌菌株的频率要低得多（P = 0.016，相对风险：0.319； 95％Cl：0.12-0.86）。慢性铜绿假单胞菌感染是罕见的，因为最近采用了早期的抗生素根除方案。囊性纤维化患者的主动免疫降低了铜绿假单胞菌感染的风险，因此可能有助于延长这些患者的生存期。

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