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预防伤寒热的Typhim Vi疫苗:在肯尼亚进行的一项临床试验。

Typhim Vi vaccine against typhoid fever: a clinical trial in Kenya.

作者信息

Mirza N B, Wamola I A, Estambale B A, Mbithi E, Poillet M

机构信息

Department of Medical Microbiology, University of Nairobi, Kenya.

出版信息

East Afr Med J. 1995 Mar;72(3):162-4.

PMID:7796767
Abstract

Safety, tolerance and immunogenicity of the purified Vi polysaccharide vaccine (Typhim Vi) against typhoid fever was evaluated in primary school children aged 5-15 years. A total of 435 children were vaccinated, each with a single intramuscular injection in the left deltoid muscle. One hundred and ten children were randomly selected for blood samples on day 0 (pre vaccination) and day 30 (post vaccination). Vi antibodies studied by Radio immuno assay (RIA) on 97(88%) paired sera showed a seroconversion rate of 76.2% and seroprotection rate after vaccination was 74.2%, while 6.2% of children already had protective immunity before vaccination. The vaccine was well tolerated. Most commonly reported reactions were mild pain at site of injection (83%), and a few complained of mild swelling (4.6%), induration (1.1%), itching (1.1%) and headaches (1.4%). All reactions were of mild severity and disappeared within 24 to 48 hours.

摘要

在5至15岁的小学生中评估了纯化Vi多糖疫苗(伤寒Vi疫苗)预防伤寒热的安全性、耐受性和免疫原性。共有435名儿童接种疫苗,均在左三角肌进行单次肌肉注射。随机选择110名儿童在第0天(接种前)和第30天(接种后)采集血样。通过放射免疫分析(RIA)对97份(88%)配对血清进行的Vi抗体研究显示,血清转化率为76.2%,接种后血清保护率为74.2%,而6.2%的儿童在接种前已有保护性免疫力。该疫苗耐受性良好。最常报告的反应是注射部位轻度疼痛(83%),少数人抱怨有轻度肿胀(4.6%)、硬结(1.1%)、瘙痒(1.1%)和头痛(1.4%)。所有反应均为轻度,在24至48小时内消失。

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