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目的评价b型流行性感冒嗜血杆菌结合疫苗(Haemophilus Influenzae Typeb Conjugate Vaccine,Hib)[磷酸多核糖基核糖醇-白喉毒素突变体197(Polyribosylribitol Phosphate-Cross Reacting Material197,PRP-CRM197)]在13～59月龄儿童中使用的安全性和免疫原性。方法选择728名13～59月龄儿童,按1:1的比例随机分配到试验组(365人)和对照组(363人),分别肌内注射接种1剂PRP-CRM197或Hib[PRP-T(Tetanus Toxoid,TT;破伤风类毒素)],观察接种后7d内的局部和全身反应,收集接种后30d内的不良事件和用药情况。在接种疫苗前和接种疫苗后30d采集静脉血,用酶联免疫吸附试验检测抗-PRP抗体(Antibody to PRP,Anti-PRP)。结果分别有99%和100%接种PRP-CRM197和PRP-T的受试者,达到了短期[≥0.15微克/毫升(g/ml)]和长期(≥1.0g/ml)血清保护性Anti-PRP水平。两种疫苗的安全性相似。结论 Hib(PRP-CRM197)的耐受性良好,免疫原性不劣于Hib(PRP-T),为99%的受试者提供了血清保护性Anti-PRP。Hib(PRP-CRM197)可在13～59月龄儿童中进行免疫。临床试验注册国家食品药品监督管理局《药物临床批件》2008L03160。
Objective To evaluate the efficacy and safety of Haemophilus Influenzae Typeb Conjugate Vaccine (Hib) [Polyribosylribitol Phosphate-Cross Reacting Material 197 (PRP-CRM197) Safety and immunogenicity in 59-month-old children. METHODS: A total of 728 children aged 13-59 months were enrolled in this study. They were randomized to test group (365) and control group (363) according to the ratio of 1: 1, and inoculated intraperitoneally with 1 dose of PRP-CRM197 or Hib [PRP-T (Tetanus Toxoid, TT; tetanus toxoid)]. The local and systemic reactions within 7 days after inoculation were observed. The adverse events and drug use within 30 days after inoculation were collected. Venous blood was collected 30 days before vaccination and after vaccination, and anti-PRP antibody (Anti-PRP) was detected by enzyme-linked immunosorbent assay. RESULTS: 99% and 100% of subjects vaccinated with PRP-CRM197 and PRP-T achieved short-term [≥0.15 μg / ml] and long-term (≥1.0 g / ml) serum protective Anti- PRP level. The safety of both vaccines is similar. Conclusions Hib (PRP-CRM197) is well tolerated and not less immunogenic than Hib (PRP-T), providing serum-protective anti-PRP to 99% of subjects. Hib (PRP-CRM197) is immunized in children aged 13 to 59 months. Clinical Trial Registration State Food and Drug Administration “Drug Clinical Approval” 2008L03160.