Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe
Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe
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DOI：
10.1016/j.jpeds.2007.02.044
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发表时间：
2007-08-01
影响因子：
5.1
通讯作者：
Malerczyk, Claudius
中科院分区：
文献类型：
--
作者：
Kamoltham, Thavatchai;Thinyounyong, Wirawan;Malerczyk, Claudius
目的探讨纯化鸡胚细胞疫苗（PCECV）在泰国5 ~ 8岁学龄儿童暴露前皮内预防狂犬病的安全性和免疫原性。在一项随机、开放标签、11期临床试验中，703名学童在第0天和第28天或第0、7和28天接受2或3次0.1 mL PCECV （Rabipur (R)）皮内注射。在206名儿童中，在初次接种系列疫苗一年后给予两次模拟暴露后加强剂量。采用快速荧光聚焦抑制法测定狂犬病毒中和抗体（RVNA）滴度。结果：在泰国学龄儿童中，暴露前接种3剂皮内PCECV可产生足够的免疫。响应。初次接种后，所有受试者的RVNA滴度均为2tt)>= 0.5 IU/mL，在初次接种后1年进行两次模拟暴露后强化免疫后，RVNA滴度迅速升高。未发生严重药物不良反应。结论PCECV狂犬病暴露前免疫接种是安全的、具有免疫原性的，在狂犬病流行地区实施PCECV狂犬病暴露前免疫可挽救许多儿童的生命。
Objective To demonstrate the safety and immunogenicity of intradermal rabies pre-exposure prophylaxis with purified chick embryo cell vaccine (PCECV) in schoolchildren age 5 to 8 years in Thailand.Study design In a randomized, open-label, phase 11 clinical trial, 2 or 3 intradermal doses of 0.1 mL PCECV (Rabipur (R)) were administered to 703 schoolchildren on days 0 and 28 or on days 0, 7, and 28. In 206 children, 2 simulated post-exposure booster doses were given I year after the primary vaccination series. Rabies virus- neutralizing antibody (RVNA) titers were determined by the rapid fluorescent focus inhibition test.Results In school-age children in Thailand, a pre-exposure immunization regimen of 3 intradermal doses of PCECV produced adequate immune. responses. After primary vaccination, all subjects developed RVNA titers 2tt)>= 0.5 IU/mL and demonstrated a rapid increase in RVNA titer after 2 simulated post-exposure booster immunizations I year after the primary vaccination series. No serious adverse drug reactions occurred.Conclusions Rabies pre-exposure immunization with PCECV is safe and immunogenic, and its implementation could save the fives of many children in rabies-endemic areas.