国产b型流感嗜血杆菌结合疫苗PRP-TT加强免疫效果评价  

Immune Effect of a Booster with Domestic Haemophilus influenzae Type b PRP-TT Conjugate Vaccine

作　　者：李亚南[1] 乔瑞洁[2] 李红[1] 刘佳[2] 王浩[2] 史晓玲[2] 叶强[1] 谢贵林[2] 

机构地区：[1]中国药品生物制品检定所菌种室,北京100050 [2]兰州生物制品研究所第一研究室,兰州730046

出　　处：《中国生物制品学杂志》2011年第2期213-215,224,共4页Chinese Journal of Biologicals

基　　金：科技部疫苗生产关键技术研究开发(2008BA166B01)

摘　　要：目的评价国产b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)结合疫苗PRP-TT的加强免疫效果。方法分别用安儿宝和呵儿贝两种Hib结合疫苗,对在广西柳州市常住儿童进行3、4、5月龄3针免疫,1年后,进行第4剂加强免疫。分别于3针免疫1年后和加强免疫1个月后采血,分离血清,采用ELISA和体外杀菌实验(Serum bactericidal assay,SBA)分别检测免疫前后血清IgG抗体浓度和加强免疫后SBA抗体滴度。结果安儿宝和呵儿贝疫苗3针免疫1年后,血清IgG抗体几何平均数浓度(Geometric mean concentrations,GMCs)分别为3.17μg/ml和3.00μg/ml,二者差异无统计学意义(P>0.05);其中,IgG抗体浓度在1.00μg/ml以上的血清所占的比例分别为79%(62/78)和76%(115/152),二者差异无统计学意义(P>0.05)。加强免疫后1个月,两种疫苗免疫血清中IgG抗体GMCs分别为71.33μg/ml和65.35μg/ml,二者差异无统计学意义(P>0.05);IgG抗体浓度均能100%达1.00μg/ml以上。两种疫苗加强免疫后的血清IgG抗体浓度与各自加强免疫前比较,差异均有统计学意义(P<0.05)。加强免疫后,两种疫苗免疫血清的SBA抗体滴度分别为5 263和4 637,二者差异无统计学意义(P>0.05)。两种疫苗免疫后血清IgG抗体浓度和SBA抗体滴度均具有相关性(r值分别为0.696和0.689,P<0.05)。结论 3针免疫1年后,两种疫苗免疫血清中IgG抗体仍保持较高的水平,第4剂加强免疫后,抗体水平迅速显著升高,100%达1.00μg/ml以上,且具有有效的体外杀菌功能。Objective To evaluate the immune effect of a booster with domestic Haemophilus influenzae type b（Hib） PRP-TT conjugate vaccine.Methods The infants resided in Liuzhou City,Guangxi Zhuang Autonomous Region,China were inoculated with two kinds of PRP-TT conjugate vaccine（Anerbao and Heerbei） respectively,for 3 times at ages of 3,4 and 5 months,and boosted with the same kind of vaccine 12 months later.The serum samples were collected 12 month after the 3rd dose and one month after the booster,and determined for IgG titers by ELISA and serum bactericidal assay（SBA） respectively.Results The geometric mean concentrations（GMCs） of serum IgG of infants 12 months after inoculation with 3 doses of Anerbao and Heerbei were 3.17 and 3.00 μg/ml respectively,which showed no significant difference（P 0.05）.The percentages of serum samples with antibody concentration of more than 1.00 μg/ml were 79%（62 / 78） and 76%（115 / 152） respectively,which showed no significant difference（P 0.05）.One month after the booster,the GMCs of serum IgG of infants inoculated with the two kinds of conjugate vaccines were 71.33 and 65.35 μg/ml respectively,which showed no significant difference（P 0.05）,while the percentage of serum samples with antibody concentration of more than 1.00 μg/ml was 100%.The serum IgG concentration after booster with each vaccine was significantly higher than that before booster（P 0.05）.The SBA titers of serum IgG after booster with Anerbao and Heerbei were 5 263 and 4 637 respectively,which showed no significant difference（P 0.05）.However,the serum IgG concentrations after inoculation with the two kinds of conjugate vaccines were related to the corresponding SBA titers（r = 0.696,0.689,P 0.05）.Conclusion The serum IgG 12 months after inoculation with two kinds of PRP-TT conjugate vaccines for 3 times remained at high levels,and increased rapidly after a booster,all of which reached more than 1.00 μg/ml and showed effective bactericidal activities in vitro.

关 键 词：嗜血菌 流感 b型 疫苗 结合 免疫接种 加强 免疫效果 

分 类 号：R378.41[医药卫生—病原生物学] R392-33[医药卫生—基础医学]