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在泰国儿童中,于生命第二年使用无细胞百日咳联合疫苗进行初免后,接种白百破-灭活脊髓灰质炎病毒疫苗//b型流感嗜血杆菌结合疫苗(百达生)加强针的免疫原性和安全性。

Immunogenicity and safety of a DTaP-IPV//PRP-T vaccine (Pentaxim) booster during the second year of life in Thai children primed with an acellular pertussis combined vaccine.

作者信息

Thisyakorn Usa, Pancharoen Chitsanu, Chuenkitmongkol Sunate, Ortiz Esteban

机构信息

Department of Pediatrics, Faculty of Medicine Chulalongkorn University Hospital, Bangkok, Thailand.

出版信息

Southeast Asian J Trop Med Public Health. 2009 Mar;40(2):282-94.

Abstract

This study assessed the booster immune response to a pentavalent combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated-Hib polysaccharide antigens, (DTaP-IPV//PRP-T, Pentaxim, an AcXim family vaccine) at 18-24 months of age. Study subjects received a three-dose primary vaccination at 2, 4 and 6 months with a hexavalent vaccine containing the same antigens plus recombinant hepatitis B surface antigen. Antibody concentrations were measured immediately before and one month after vaccination. Reactogenicity and safety were evaluated from parent reports. Before the booster dose, 92.9% of the 156 children included in this study still had anti-PRP antibody titers > or = 0.15 microg/ml. Seroprotective concentrations of anti-diphtheria, tetanus and poliovirus antibodies were maintained in 97 to 100% of subjects in the interval between primary and booster vaccination. One month after the booster dose, all subjects had seroprotective anti-PRP (> or = 1 microg/ml), diphtheria and tetanus (> or = 0.1 IU/ml) and poliovirus types 1, 2, 3 (> or = 8 1/dil) antibody levels. At least 92.3% of subjects had 4-fold increases in concentrations of anti-pertussis antigens from pre- to post-booster dose. Geometric mean titers (GMTs) increased from 3.8 to 181.2 EU/ml and from 18.0 to 289.7 EU/ml for anti-PT and anti-FHA, respectively. The anti-PRP GMT increased from 1.6 to 58.0 microg/ml. The pentavalent DTaP-IPV//PRP-T vaccine booster was well tolerated and highly immunogenic, following primary vaccination with a hexavalent vaccine.

摘要

本研究评估了18至24月龄儿童对一种包含白喉、破伤风、无细胞百日咳、灭活脊髓灰质炎病毒和结合型b型流感嗜血杆菌多糖抗原的五价联合疫苗(DTaP-IPV//PRP-T,百白破-脊灰-流感嗜血杆菌联合疫苗,AcXim家族疫苗)的加强免疫反应。研究对象在2、4和6月龄时接受了三剂含相同抗原及重组乙肝表面抗原的六价疫苗基础免疫。在接种疫苗前及接种后1个月测量抗体浓度。根据家长报告评估反应原性和安全性。在加强剂量前,本研究纳入的156名儿童中92.9%的抗PRP抗体滴度仍≥0.15μg/ml。在基础免疫和加强免疫期间,97%至100%的受试者维持了抗白喉、破伤风和脊髓灰质炎病毒抗体的血清保护浓度。加强剂量接种1个月后,所有受试者的抗PRP(≥1μg/ml)、白喉和破伤风(≥0.1IU/ml)以及1、2、3型脊髓灰质炎病毒(≥8IU/稀释度)抗体水平均达到血清保护水平。至少92.3%的受试者加强免疫后抗百日咳抗原浓度较免疫前增加了4倍。抗百日咳毒素(PT)和抗丝状血凝素(FHA)的几何平均滴度(GMT)分别从3.8EU/ml增至181.2EU/ml和从18.0EU/ml增至289.7EU/ml。抗PRP的GMT从1.6μg/ml增至58.0μg/ml。在接受六价疫苗基础免疫后,五价DTaP-IPV//PRP-T疫苗加强免疫耐受性良好且免疫原性高。

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