三组分的无细胞百白破联合疫苗安全性和免疫原性研究

A Study on Immunogenicity and Safety of Adsorbed Acellular DTP Vaccine Prepared with Separately Purified Antigens

葛兰素史克公司的吸附无细胞百白破联合疫苗 ,采用了分别提取百日咳毒素 (PT)、丝状血凝素 (FHA)、6 9kD外膜蛋白 (PRN ,粘附素 )三种抗原后 ,再按照各自的含量配合制备而成。为考察该疫苗的安全性和免疫原性 ,在广西壮族自治区横县选择 3～ 6月龄、足月分娩、未接种过百白破联合疫苗的健康婴儿进行了临床研究。安全性结果表明 :受试者全身中反应发生率为 1 2 % (17人次 / 1386人次 ) ,弱反应发生率为 11 5 % ,无强反应发生。受试者局部淋巴结无异常反应 ,注射部位弱反应发生率为 0 5 % (7人次 / 1386人次 ) ,无中、强反应发生。免疫原性结果为 :受试者白喉抗体阳转率为 99 2 % ;破伤风抗体阳转率为 99 2 % ;抗PT抗体的阳转率为 96 4 % ;抗百日咳FHA抗体的阳转率为 99 3% ;抗粘附素抗体水平免疫后比免疫前增长≥ 4倍的占 94 5 %。结果证明 :该疫苗接种后具有低反应性和良好的免疫原性。

The adsorbed acellular DTP vaccine (DTaP) manufactured by Smithkline-Beecham Company is a new kind DTP vaccine. The pertussis protective antigens in DTaP vaccine include PT、FHA and 68kD PRN which were purified separately. In order to evaluated the efficacy and safety of the DTaP, we administered the DTaP vaccine to infants aged 3～6 months in Guangxi Autonomous Region. The safety results were as follows. The mild and moderate systemic and local adverse reactions were 11 5% and 1 2% respectively.There was no severe adverse reaction. Immunogenicity results showed the positive seroconversion rates for diphtheria and tetanus were 99 2% and 99 2% respectively, the positive seroconversion rates for PT, FHA and 69kD PRN were 96 4%, 99 3% and 94 5% respectively. Clinical trial data indicated that the immunogenicity and safety of the adsorbed acellular DTP vaccine have reached a satisfactory level.