吸附精制百日咳菌苗人体接种反应及血清学效果观察报告

田效恩; 胡久珍; 何家龙; 宋英; 刁琳琪; 贾庆梅; 荆瑞芳; 陈媛; 韩焕霞; 葛继体; 秦进才; 侯启明; 祖涛; 梁亚文; 关瑛; 何长民; 杨晓明; 陈平纡; 陈爱荣; 程夷; 边淑娟; 张锡云; 王祖森; 张蓉; 高红

Abstract

田效恩,胡久珍,何家龙,宋英,刁琳琪,贾庆梅,荆瑞芳,陈媛,韩焕霞,葛继体,秦进才,侯启明,祖涛,梁亚文,关瑛,何长民,杨晓明,陈平纡,陈爱荣,程夷,边淑娟,张锡云,王祖森,张蓉,高红.吸附精制百日咳菌苗人体接种反应及血清学效果观察报告[J].Chinese journal of Epidemiology,1993,14(3):155-159

吸附精制百日咳菌苗人体接种反应及血清学效果观察报告

An Observation on Immunization Reaction and Serological Effect of Adsorbed Purified Pertussis Vaccine

Received:December 07, 1992 Revised:February 03, 1993

DOI：

KeyWord: 吸附精制百日咳菌苗全细胞百日咳菌苗白细胞增多促进因子（LPF）丝状血凝素（FHA）抗LPF抗体抗FHA抗体

English Key Word: Adsorbed purified pertussis vaccine Whole cell pertussis vaccine Anti-LPE antibody Anti-FHA antibody hemagglutinin

FundProject:

Author Name	Affiliation
Tian Xiaoen	Henan Provincial Hygiene and Epidemic Prevention Station, Zhengzhou 450003
胡久珍	Henan Provincial Hygiene and Epidemic Prevention Station, Zhengzhou 450003
何家龙	Henan Provincial Hygiene and Epidemic Prevention Station, Zhengzhou 450003
宋英	Henan Provincial Hygiene and Epidemic Prevention Station, Zhengzhou 450003
刁琳琪	Henan Provincial Hygiene and Epidemic Prevention Station, Zhengzhou 450003
贾庆梅	Henan Provincial Hygiene and Epidemic Prevention Station, Zhengzhou 450003
荆瑞芳	郑州市金水区防疫站
陈媛	郑州市金水区防疫站
韩焕霞	郑州市金水区防疫站
葛继体	郑州市金水区防疫站
秦进才	中国药品生物制品检定所
侯启明	中国药品生物制品检定所
祖涛	中国药品生物制品检定所
梁亚文	中国药品生物制品检定所
关瑛	中国药品生物制品检定所
何长民	卫生部兰州生物制品研究所
杨晓明	卫生部兰州生物制品研究所
陈平纡	卫生部兰州生物制品研究所
陈爱荣	卫生部兰州生物制品研究所
程夷	卫生部兰州生物制品研究所
边淑娟	卫生部兰州生物制品研究所
张锡云	卫生部兰州生物制品研究所
王祖森	卫生部兰州生物制品研究所
张蓉	卫生部兰州生物制品研究所
高红	卫生部兰州生物制品研究所

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Abstract:

在郑州市12家省、市医院进行了所属地段内儿童国内首次吸附精制百日咳菌苗人体接种的接种反应及血清学效果观察。I期安全性观察接种8名成人及随后20名婴幼儿,均未见局部反应,仅后者有4例体温弱反应(37.6℃~38.0℃)。II期观察中,三次记录吸附精制百日咳菌苗组102名接种者局部中反应(2.6~5.0cm)1人次,而全细胞百日咳菌苗组100名为17人次,前者无强反应(5.1cm),而后者有3人次,前者104名接种者全身中反应为8人次,后者101名高达39人次,并且前者无强反应,后者有2人次。说明吸附精制百日咳菌苗接种反应轻微,这方面较全细胞百日咳菌苗明显优越。吸附精制百日咳菌苗组90名儿童免后1个月的血清凝集素几何平均滴度为817,全细胞菌苗85名为1422,对照制剂77名为8.79。两苗免后抗体比免前显著升高(P<0.01);抗LPF抗体和抗FHA抗体吸附精制百日咳菌苗接种的60名儿童免后抗体分别达到24.17EU/ml±3.9421(免前4.918EU/ml±0.9282)和38.850EU/ml±7.2466(免前10.698EU/ml±1.5304),均呈极显著性升高(P<0.01),与全细胞菌苗结果相似,对照剂组抗体不见升高。

English Abstract:

An observation on immunization reaction and serological effect of adsorbed purified pertussis vaccine for the first time in China had been carried out in Zhengzhou. Phase I field trial had been conducted on 8 adults and 20 children in whom there was no local reaction and temperature reaction in adults and only mild temperature reaction (37.6℃~38℃) in 4 children. Phase II field trial showed that the adsorbed purified pertussis vaccine manifested trivial reaction, none developed severe temperature reaction (39.1℃), and 8 person-times of moderate temperature reaction (38.1℃~39.1℃) occurred in 100 children after 3 doses. Whereas. 2 person-times of severe reaction and 39 persontimes of mild reaction occurred in 101 children after receiving the whole cell pertussis vaccine. None showed local severe reaction (5.1cm) and 1 person-time of mild local reaction appeared at 48 hours after each of 3 doses of adsorbed purified pertussis vaccine (102, 102, 98 children, respectively); Whereas, 3 persontimes of severe local reaction and 17 person-times of mild local reaction occurred after each of 3 doses of whole cell pertussis vaccine (97, 100, 97 children, respectively). Satisfactory immunogenicity of the adsorbed purified pertussis vaccine was confirmed. The high serum hemagglutinin titer was achieved in 90 children, the GMT reached 817 (9.16 for preimmunization), and titers reaching 1:320 and over (a level protecting human from being infected) accounted for 84.4 percent. The average levels of anti-LPF and anti-FHA antibodies in 60 and 53 persons attained to 24.17 ±3.9421 EU/ml and 38.85±7.2466 EU/ml, respectively.

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