ACYW135群脑膜炎球菌多糖疫苗安全性和免疫原性研究(15页).doc

PAGE  PAGE 15 ACYW135群脑膜炎球菌多糖疫苗安全性和免疫原性研究 摘要 目的 研究四价脑膜炎球菌多糖疫苗免疫后抗体阳转情况及安全性，为制订防治策略提供依据。 方法 符合要求的810名受试者接种四价脑膜炎球菌多糖疫苗，接种疫苗后观察30分钟即时反应，系统随访受试者72小时,并定期随访4-6周，检测并分析比较其抗体阳转（4倍增长）率、 抗体几何平均滴度（GMT）及不良反应率。 结果 免疫后A、C、W135、Y群脑膜炎球菌血清杀菌抗体阳转（4倍增长）率为98.14%、97.61%、96.82%、98.84%，抗体GMT分别为1︰250.41、1︰263.16、1︰173.36、1︰196.81，试验组与对照组、不同年龄组间免疫后抗体阳转（4倍增长）率无统计学差异，幼儿、儿童组抗体水平高于成人组，未观察到严重不良反应，达到预期疗效。 结论 成都康华生物制品有限公司的ACYW135群脑膜炎球菌多糖疫苗安全性良好，有效性极高，免疫预防中医生可放心推广使用该疫苗，对减少流脑发病数有重要意义。 关键词 流脑；流脑疫苗；抗体检测 A study on safety and immunogenicity of A、C、Y、W135 group of epidemic cerebrospinal meningitis polysaccharide vaccine Cai Yong, Zhou Rong, Li Shengyou,Hou Wenli,Feng Xiao Chengdu Kanghua Biological Products Co.,Ltd. No.182 Beijing Road Chengdu,China Abstract Objective Study the antibody positive conversion rates and safety of tetravalent meningococcal polysaccharide vaccine to provide references for a effective preventive and curative measure. Methods Immunize 810 healthy volunteers with tetravalent meningococcal polysaccharide vaccine，observed 30 minutes of instant response after vaccination, subjects were systematic follow-up visited of 72 hours and regular follow-up visited 4～6 weeks．Determination of the antibody positive seroconversion rates、antibody geometric mean titer(GMT) and the adverse reaction rate. Results After immunized the A、C、Y、W135 group of epidemic cerebrospinal meningitis serum bactericidal antibodies positive conversion rates are 98.14%、97.61%、96.82%、98.84%, antibody geometric mean titer(GMT) are 1︰250.41、1︰263.16、1︰173.36、1︰196.81,After immunized, the test group and the control group, antibody positive seroconversion rates are no statistical difference among different age groups, childrens group antibody levels than the adult group, No serious adverse effects were observed. The experiments achieve the desired effect. Conclusions the A、C、Y、W135 group of epidemic cerebrospinal meningitis polysaccharide vaccine produced by chengdu kanghua biologicals Products Co.,Ltd has a mil