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肠溶胶囊剂型Ty21a口服伤寒活疫苗的大规模现场试验。

Large-scale field trial of Ty21a live oral typhoid vaccine in enteric-coated capsule formulation.

作者信息

Levine M M, Ferreccio C, Black R E, Germanier R

出版信息

Lancet. 1987 May 9;1(8541):1049-52. doi: 10.1016/s0140-6736(87)90480-6.

Abstract

Three doses, given within one week, of Ty21a attenuated Salmonella typhi oral vaccine in an enteric-coated formulation provided 67% efficacy for at least 3 years in a randomised, placebo-controlled field trial involving 109,000 schoolchildren in Santiago, Chile. Increasing the interval between doses to twenty-one days did not enhance protection. Significantly less protection followed administration of vaccine in gelatin capsules with sodium bicarbonate. Ty21a provides the same level of protection as the heat/phenol-inactivated whole cell parenteral vaccine but differs in not causing adverse reactions. Ty21a may now be regarded as a practical public health tool.

摘要

在智利圣地亚哥一项涉及109,000名学童的随机、安慰剂对照现场试验中,采用肠溶包衣剂型的Ty21a减毒伤寒沙门氏菌口服疫苗,一周内分三剂服用,至少3年的效力为67%。将剂量间隔延长至21天并不能增强保护效果。服用含碳酸氢钠的明胶胶囊疫苗后,保护效果明显较差。Ty21a提供的保护水平与热/苯酚灭活全细胞肠外疫苗相同,但不同之处在于不会引起不良反应。Ty21a现在可被视为一种实用的公共卫生工具。

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