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加纳两种无细胞百日咳-白喉-破伤风疫苗用于初次免疫的随机对照试验:抗体反应和不良反应

A randomized controlled trial of two acellular pertussis-diphtheria-tetanus vaccines in primary immunization in Ghana: antibody responses and adverse reactions.

作者信息

Hori H, Afari E A, Akanmori B D, Kamiya Y, Sakatoku H, Nkrumah F K, Kamiya H, Chazono M, Fukai K

机构信息

Noguchi Memorial Institute for Medical Research, University of Ghana, Legon.

出版信息

Ann Trop Paediatr. 1994;14(2):91-6. doi: 10.1080/02724936.1994.11747699.

DOI:10.1080/02724936.1994.11747699
PMID:7521636
Abstract

Two acellular pertussis vaccines combined with diphtheria and tetanus toxoids (APDT vaccines) were compared with a whole cell PDT (WCPDT) vaccine in primary immunization in Ghana. One is a liquid vaccine which is used for general immunization in Japan and the other is a freeze-dried vaccine newly developed as a heat-stable vaccine. Eighty-nine infants were recruited in the study. Sixty-eight who completed three doses of the immunization were assessed for immunological responses. Twenty-one dropped out because of sickness or moving from the study area. A total of 242 vaccinations in 89 infants were followed up for adverse reactions. Geometric mean titres (GMTs) to filamentous haemagglutinin in the two APDT vaccinees were significantly higher than in the WCPDT recipients. GMTs to pertussis toxin, diphtheria and tetanus toxoids were not significantly different among the three groups. Seropositive rates to pertussis antigens, tetanus and diphtheria toxoids were 94.4 to 100% in the two APDT vaccines. Systemic reactions within 7 days of inoculation were similarly low in the three groups, but significantly fewer infants had local reactions after either of the two APDT vaccines than after the WCPDT vaccine.

摘要

在加纳的初次免疫中,将两种与白喉和破伤风类毒素联合的无细胞百日咳疫苗(APDT疫苗)与全细胞百日咳、白喉和破伤风疫苗(WCPDT疫苗)进行了比较。一种是液体疫苗,在日本用于常规免疫,另一种是新开发的冻干疫苗,作为热稳定疫苗。89名婴儿参与了该研究。对完成三剂免疫的68名婴儿进行了免疫反应评估。21名婴儿因患病或搬离研究区域而退出。对89名婴儿共242次接种进行了不良反应随访。两种APDT疫苗接种者对丝状血凝素的几何平均滴度(GMT)显著高于WCPDT疫苗接种者。三组中对百日咳毒素、白喉和破伤风类毒素的GMT无显著差异。两种APDT疫苗对百日咳抗原、破伤风和白喉类毒素的血清阳性率为94.4%至100%。接种后7天内的全身反应在三组中同样较低,但与WCPDT疫苗相比,两种APDT疫苗接种后出现局部反应的婴儿明显较少。

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