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一种抗原含量降低的白喉-破伤风-无细胞百日咳疫苗作为新加坡成年人单剂量加强针的免疫原性和反应原性

Immunogenicity and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine as a single-dose booster in Singaporean adults.

作者信息

Chan S H, Tan P T N, Han H H, Bock H L

机构信息

Department of Microbiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

出版信息

Singapore Med J. 2006 Apr;47(4):286-90.

Abstract

INTRODUCTION

Older children and adults, susceptible to pertussis because of waning immunity, may serve as a reservoir of infection, leading to severe disease among young unvaccinated infants. Booster diphtheria-tetanus-acellular pertussis (dTpa) vaccination in older age groups is rare in Singapore, one reason being the increase in reactogenicity with each successive dose. The aim of this study was to assess the immunogenicity, safety and reactogenicity of a reduced antigen, combined dTpa vaccine as a single booster dose in healthy adults aged 18 years or older.

METHODS

A total of 150 healthy adults, 18 to 60 years of age, received a single dose of GlaxoSmithKline Biologicals' dTpa vaccine with reduced content for diphtheria and pertussis, with measurement of pre- and post-vaccination antibody titres.

RESULTS

Prior to vaccination, 71.6 percent and 92.6 percent of the subjects had anti-diphtheria and anti-tetanus antibody levels greater than or equal to 0.1 IU/mL, respectively. 46.7 percent, 98.5 percent and 44.4 percent of subjects were seropositive for pertussis toxin (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antibodies, respectively. One month after vaccination, there was an increase in geometric mean titres from pre-vaccination to post-vaccination blood samples for anti-diphtheria (greater than seven-fold), anti-tetanus (greater than five-fold), anti-PT (greater than 11-fold), anti- FHA (greater than 25-fold) and anti-PRN (greater than 31-fold) antibodies. Solicited grade three local symptoms (pain, redness and swelling) were reported in 14.1 percent, 8.1 percent and 10.4 percent of subjects, respectively. No serious adverse events were reported.

CONCLUSION

In summary, the dTpa vaccine is immunogenic, safe and well-tolerated in Singaporean adults.

摘要

引言

大龄儿童和成年人由于免疫力下降易感染百日咳,可能成为感染源,导致未接种疫苗的幼儿患上严重疾病。在新加坡,大龄人群中很少接种白喉-破伤风-无细胞百日咳(dTpa)加强疫苗,原因之一是随着接种剂量的增加,反应原性也会增强。本研究的目的是评估一种抗原含量降低的联合dTpa疫苗作为单剂加强针在18岁及以上健康成年人中的免疫原性、安全性和反应原性。

方法

共有150名年龄在18至60岁的健康成年人接种了一剂葛兰素史克生物制品公司生产的白喉和百日咳含量降低的dTpa疫苗,并检测了接种前后的抗体滴度。

结果

接种疫苗前,分别有71.6%和92.6%的受试者抗白喉和抗破伤风抗体水平大于或等于0.1 IU/mL。分别有46.7%、98.5%和44.4%的受试者百日咳毒素(PT)、丝状血凝素(FHA)和百日咳杆菌粘附素(PRN)抗体呈血清阳性。接种疫苗一个月后,抗白喉(大于7倍)、抗破伤风(大于5倍)、抗PT(大于11倍)、抗FHA(大于25倍)和抗PRN(大于31倍)抗体的几何平均滴度从接种前到接种后的血样中有升高。分别有14.1%、8.1%和10.4%的受试者报告了三级局部症状(疼痛、发红和肿胀)。未报告严重不良事件。

结论

总之,dTpa疫苗在新加坡成年人中具有免疫原性、安全性且耐受性良好。

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