23价肺炎球菌多糖疫苗临床试验  

Clinical Effect of 23-valent Pneumococcal Polysaccharide Vaccine

作　　者：杨耀 栗克喜 宋绍忠 张云 江山 谢全海 兰芳 黄剑 黎云东 李凤祥[2] 袁曾麟[2] 郭淑英[2] 石继春[2] 何莉[2] 

机构地区：[1]成都生物制品研究所,四川成都610023 [2]中国药品生物制品检定所

出　　处：《预防医学情报杂志》2007年第4期390-391,共2页Journal of Preventive Medicine Information

摘　　要：目的评价23价肺炎球菌多糖疫苗的安全性和免疫原性。方法23价肺炎球菌多糖疫苗免疫不同年龄组人群,观察局部及全身反应,并检测血清抗体滴度。结果试验组接种后出现的注射部位总疼痛率为30.8%。2人注射部位出现弱、中反应的红肿,反应率为0.23%。全身反应主要为弱反应,反应率为0.6%。试验组免后抗体平均滴度4.03,阳性对照组为4.15;抗体阳转率试验组为86.4%,阳性对照组为72.5%。试验组与阳性对照组全身发热和局部疼痛反应差异无统计学意义。试验组与阳性对照组的免疫原性相近。结论23价肺炎球菌多糖疫苗是安全有效的。Objective To evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine.Methods Persons of different ages were immunized by the vaccine, local and systemic reaction were observed, and the antibody titre determined.Results After injection, there were 30.8% of the persons felt the pain at the injection site.Two persons（0.23%） revealed weakness and medium erythema. Most of the systemic reaction was the weak reaction（0.6%）.The titre of antibody average concentration was 4.03 in test group but 4.15 in positive control group.The test group＇s positive conversion rate was 86.4%, and it was 72.5% in pesitive control group.The reaction of local pain and systemic temperature had no significant differences between the test group and the positive control group.Immunogenicity was close between the two groups.Conclusion 23-valent pneumococcal polysaccharide vaccine developed by us is safe and effective.

关 键 词：23价肺炎球菌多糖疫苗 临床研究 抗体滴度 

分 类 号：R563.1[医药卫生—呼吸系统]