摘要
目的 观察武汉生物制品研究所有限责任公司（以下简称武汉公司）吸附无细胞百白破联合疫苗（diphtheria,tetanus and acellular pertussis combined vaccine,DTaP）的免疫原性和免疫持久性。方法 于2007年9月在成都地区选择670名未接种过百白破联合疫苗,无百日咳、白喉、破伤风疾病史的足月出生的健康婴儿,按2：1比例随机接种3剂观察疫苗（武汉公司生产的DTaP）和对照疫苗（某厂家生产的DTaP）,进行基础免疫,每剂间隔1个月,2009年3月进行加强免疫,接种剂量均为0.5 ml/（剂.人）。基础免疫接种前和全程接种后30～50 d、加强免疫前和加强免疫后1个月、1、2、3年分别采集静脉血,分离血清,经ELISA法测定百日咳毒素抗体（pertussis toxin antibody,PT-Ab）、丝状凝集素抗体（filamentous hemagglutinin antibody,FHA-Ab）、白喉抗体（diphtheria antibody,D-Ab）、破伤风抗体（tetanus antibody,T-Ab）GMT,若免疫前抗体为阳性,则计算4倍增长率。结果 基础免疫试验组351例、对照组193例完成了全程接种,即544例受种者符合方案要求。DTaP基础免疫后,试验组与对照组的4种抗体阳转率及抗体4倍增长率差异均无统计学意义（P〉0.05）;试验组FHA-Ab GMT明显高于对照组,差异有统计学意义（P〈0.05）。加强免疫前,试验组与对照组4种抗体阳转率差异无统计学意义（P〉0.05）;加强免疫后1个月,试验组FHA-Ab阳转率明显高于对照组,差异有统计学意义（P〈0.05）;加强免疫后1、2、3年,试验组与对照组4种抗体阳转率和抗体GMT差异均无统计学意义（P〉0.05）;加强免疫后1年,4种抗体GMT均高于有效保护水平,加强免疫后2年,PT-Ab和FHA-Ab GMT已降至保护水平以下,加强免疫后3年,D-Ab、T-Ab GMT仍高于保护水平。结论武汉公司生产的DTaP具有较好的免疫原性和免疫持久性。
Objective To observe the immunogenicity and immune persistence of adosorbed diphtheria, tetanus and acellular pertussis combined vaccine （DTaP） manufactured by Wuhan Institute of Biological Products Co., Ltd （WIBP）. Methods A total of 670 mature healthy infants without immunization history of DTaP or history of diphtheria, tetanus and pertussis in Chengdu Region in September 2007 were selected and divided into trial and control groups according to a proportion of 2 ： 1. The infants in trial group were immunized with three doses of DTaP manufactured by WIBP, while those in control group with DTaP by a manufacturer, each at an interval of one month and a dosage of 0. 5 ml, and boosted in March 2009. Venous blood samples were collected before and 30 - 50 d after primary immunization, before and one month, 1, 2 and 3 years after booster immunization, from which sera were separated and determined for the GMTs of pertussis toxin antibody （PT-Ab）, filamentous hemagglutinin antibody （FHA-Ab）, diphtheria antibody （D-Ab） and tetanus antibody（T-Ab） by ELISA. If the infants were positive for the antibodies before immunization, the 4-fold increasing rate of GMT was calculated. Results A total of 544 infants, 351 in trial group and 193 in control group, received a full course of primary immunization according to the schedule. After primal7 immunization, no significant differences were observed in the positive conversion rates of four antibodies or the 4-fold increasing rate of antibody levels in trial and control groups （P 〉 0. 05）. However, the GMT of FHA-Ab in trial group was significantly higher than that in control group （P 〈 0. 05）. Before booster immunization, the positive conversion rates of four antibodies in trial group showed no significant difference with those in control group （P 〉 0. 05）. However, one month after booster immunization, the positive conversion rate of FHA-Ab in trial group was significantly higher than that in control group （P 〈 0. 05）. The positive
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第12期1805-1808,1811,共5页
Chinese Journal of Biologicals
关键词
无细胞百白破联合疫苗
免疫原性
免疫持久性
Diphtheria, tetanus and acellular pertussis combined vaccine （DTaP）
Immunogenicity
Immune persistence
