福氏2a痢疾结合疫苗临床安全性和免疫原性观察

Safety and Immunogencity of Shigella flexneri 2a Conjugate Vaccine in Clinic

目的观察福氏2a痢疾结合疫苗临床安全性和免疫原性。方法按随机、双盲的原则,以福氏2a痢疾结合疫苗为观察组,磷酸缓冲盐水为安慰剂对照组,进行临床安全性及免疫原性观察,比较观察组和对照组免疫后临床反应率、抗体阳转率和几何平均滴度(GMT)水平。结果福氏2a痢疾结合疫苗接种后无严重的全身反应和局部反应,与对照组比较,差异无显著意义。观察组经2针全程免疫后2周和12周,抗体阳转率分别为86.27%和79.74%;GMT分别为1∶3783.55和1∶2983.32;抗体几何平均滴度较免疫前平均增长倍数分别为12.47倍和9.83倍。全程免疫后观察组与对照组之间抗体阳转率、几何平均滴度、抗体滴度平均增长倍数比较,差异均有显著意义。结论福氏2a痢疾结合疫苗具有较好的安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of Shigella flexneri 2a conjugate vaccine in clinic.Methods A random and double blind study was carried out to evaluate the adverse reaction rate as well as antibody positive conversion rate and GMT of Shigella flexneri 2a conjugate vaccine,using phospate buffer saline as control.Results No severe local or systemic adverse reactions were observed after immunization with Shigella flexneri 2a conjugate vaccine.The local and systemic adverse reaction rates of trial group showed no significant difference with those of control group.The antibody positive conversion rates of trial group 2 and 12 weeks after 2 doses of vaccine were given were 86.27% and 79.74% respectively.The antibody GMTs of trial group after immunization were 1∶3783.55 and 1∶2983.32,which increased by 12.47 and 9.83 folds respectively compared with those before immunization.The antibody positive conversion rate as well as GMT and its increasing fold of trial group were significantly higher than those of control group.Conclusion Shigella flexneri 2a conjugate vaccine showed good safety and immunogencity in clinic.