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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。
GlaxoSmithKline’s adsorbed cell-free Bupleurum combined vaccine was obtained by extracting three antigens of pertussis toxin (PT), filamentous hemagglutinin (FHA), and 69 kD outer membrane protein (PRN, adhesin) , And then prepared in accordance with the respective content with. In order to investigate the safety and immunogenicity of the vaccine, a clinical study was conducted in Heng County, Guangxi Zhuang Autonomous Region to select healthy infants aged 3 ~ 6 months, full term delivery, and not vaccinated against dipyridamovirus. The safety results showed that the incidence of systemic reactions was 12% (17 persons / 1386 persons), and the incidence of weak reactions was 115%. No strong reaction occurred. There was no abnormal reaction in the local lymph nodes of the subjects, and the incidence of weak reaction at the injection site was 0 5% (7 persons / 1386 person-times). No moderate or strong reaction occurred. The results of immunogenicity were: diphtheria antibody positive rate of 99 2%, tetanus antibody positive rate of 99 2%, anti-PT antibody positive rate of 96 4%, anti-pertussis FHA antibody positive rate 99 3%; anti-adhesin antibody levels after immunization than pre-immune growth ≥ 4 times 94 5%. The results demonstrate that the vaccine has low reactivity and good immunogenicity after inoculation.