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采用泰国红十字会方案皮内注射狂犬病疫苗的效价要求:连续稀释的纯化鸡胚细胞狂犬病疫苗免疫原性研究。

Potency requirements of rabies vaccines administered intradermally using the Thai Red Cross regimen: investigation of the immunogenicity of serially diluted purified chick embryo cell rabies vaccine.

作者信息

Beran Jiri, Honegr Karel, Banzhoff Angelika, Malerczyk Claudius

机构信息

Department of Infectious Diseases, University Hospital, Hradec Kralove, Czech Republic.

出版信息

Vaccine. 2005 Jun 10;23(30):3902-7. doi: 10.1016/j.vaccine.2005.03.007. Epub 2005 Apr 6.

Abstract

To determine the minimum vaccine potency per intradermal dose required to elicit an adequate immune response using the Thai Red Cross (TRC) regimen (2-2-2-0-1-1), healthy volunteers received 0.1 mL volumes of PCECV containing decreasing amounts of antigen. Subjects also received HRIG to evaluate potential interference with antibody production. Results indicated that when each 0.1 mL intradermal dose of PCECV contained antigen corresponding to 0.32 IU per intramuscular dose, every subject had titers above 0.5 IU/mL by day 14. These results confirm that the current World Health Organization (WHO) recommendations for vaccine potency (2.5 IU per intramuscular dose) are sufficient for use in the Thai Red Cross intradermal regimen.

摘要

为了确定使用泰国红十字会(TRC)方案(2-2-2-0-1-1)引发足够免疫反应所需的每皮内剂量的最低疫苗效力,健康志愿者接受了0.1 mL含逐渐减少抗原量的PCECV。受试者还接受了人狂犬病免疫球蛋白(HRIG)以评估对抗体产生的潜在干扰。结果表明,当每0.1 mL皮内剂量的PCECV所含抗原相当于每肌内剂量0.32国际单位(IU)时,到第14天每个受试者的滴度均高于0.5 IU/mL。这些结果证实,世界卫生组织(WHO)目前关于疫苗效力的建议(每肌内剂量2.5 IU)足以用于泰国红十字会皮内方案。

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