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中国学龄儿童接种国产Vi伤寒多糖疫苗的再接种:安全性和免疫原性研究结果

Revaccination with locally-produced vi typhoid polysaccharide vaccine among chinese school-aged children: safety and immunogenicity findings.

作者信息

Zhou Wei-Zhong, Koo Hye-Won, Wang Xuan-Yi, Zhang Jun, Park Jin-Kyung, Zhu Fengcai, Deen Jacqueline, Acosta Camilo J, Chen Yan, Wang Hua, Galindo Claudia M, Ochiai Leon, Park Taesung, von Seidlein Lorenz, Xu Zhi-Yi, Clemens John D

机构信息

Jiangsu Provincial Center for Disease Prevention and Control, Nanjing, China.

出版信息

Pediatr Infect Dis J. 2007 Nov;26(11):1001-5. doi: 10.1097/INF.0b013e31812565bc.

Abstract

OBJECTIVE

To evaluate the safety and immunogenicity of revaccination with locally-produced Vi polysaccharide vaccine 3 years after the first dose in Chinese children aged 9 to 14 years.

METHODS

A randomized, placebo-controlled trial was conducted in Suzhou, Jiangsu, China. Six hundred and sixty-seven eligible children who had previously received a primary dose of Vi vaccine were randomly assigned to receive 1 dose of 30 mug Vi vaccine or placebo. In addition, 331 eligible children received 1 dose of Vi polysaccharide vaccine as a primary vaccination. Adverse events were followed for 28 days after vaccination. Serum samples were collected from a subgroup of participants on day 0 and day 28, and Vi antibodies were analyzed using a passive hemagglutination method.

RESULTS

Revaccination was found to be safe and immunogenic. No severe adverse events were observed. A significant increase in antibody titers after vaccination was observed among children who had and had not been previously vaccinated. Twenty-eight days after injection, the seropositive rate was 79% in both revaccination and primary injection groups; the geometric mean antibody titer was 1:40 in the primary injection group and 1:29 in the revaccination group (P = 0.24). Although the difference of attained geometric mean titers in follow-up sera was not significantly different in these 2 groups, the fold-rise of these titers from baseline was significantly higher in the primary injection group than in the revaccination group (7.7 versus 3.1, P < 0.001).

CONCLUSION

We found that revaccination using the locally produced Vi polysaccharide vaccine among Chinese school-aged children was safe and increased antibody titers. Revaccination can be used to extend the duration of protection provided by Vi polysaccharide vaccine.

摘要

目的

评估中国9至14岁儿童在首剂接种3年后再次接种国产Vi多糖疫苗的安全性和免疫原性。

方法

在中国江苏苏州进行了一项随机、安慰剂对照试验。667名先前已接种过一剂Vi疫苗的符合条件的儿童被随机分配接受1剂30μg Vi疫苗或安慰剂。此外,331名符合条件的儿童接受1剂Vi多糖疫苗作为初次接种。接种后随访28天观察不良事件。在第0天和第28天从部分参与者亚组中采集血清样本,采用被动血凝法分析Vi抗体。

结果

发现再次接种是安全且具有免疫原性的。未观察到严重不良事件。在先前接种过和未接种过的儿童中,接种后抗体滴度均显著升高。注射28天后,再次接种组和初次接种组的血清阳性率均为79%;初次接种组的几何平均抗体滴度为1:40,再次接种组为1:29(P = 0.24)。尽管这两组随访血清中获得的几何平均滴度差异无统计学意义,但初次接种组这些滴度相对于基线的升高倍数显著高于再次接种组(7.7对3.1,P < 0.001)。

结论

我们发现中国学龄儿童再次接种国产Vi多糖疫苗是安全的,并能提高抗体滴度。再次接种可用于延长Vi多糖疫苗提供的保护持续时间。

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