23价肺炎球菌多糖疫苗安全性及免疫原性现场考察

对 140名 5 5～ 70岁老人肌肉注射 2 3价肺炎球菌多糖疫苗 ,剂量为 5 75 μg 0 .5ml。于注射后观察反应 ,并于接种前及接种后 1个月分别采血 ,用ELISA改良法检测 2 3种抗体水平。疫苗接种后全身反应轻微 ,接种 6～ 8h和 2 4h内分别有 2 8人 (2 0 .0 0 % )和 38人 (2 7.14% )发生不同程度局部红肿 ,分别有 5 8人 (41.42 % )和 41人 (2 9.2 8% )局部疼痛。 48h后 ,上述局部反应明显减轻 ,72h后全部症状消失。检测 10 0名被接种者抗体滴度 ,均有良好的免疫应答 ,总抗体的几何平均滴度 (GMT)增加 2 .4倍 ,除 3型外 ,各型免前免后滴度差异均有非常显著意义 ,表明疫苗免疫原性较好。

Field Trial of Safety and Immunogenicity of 23-valent Penumococcal Polysaccharide Vaccine

The adverse reactions was observed in 140 elderly person (aged 55 70 years) 6-8,24 and 72h after being intramuscularly injected with 23-valent(575μg/0.5ml)penumococcal polysaccharidevaccine.The systemic reaction was mild. Local red and sswelling at different degrees were observed in 28(20.00%) and 38 cases(27.14%) within 6-8 and 24h respectively, while local pain were observed in 58(41.42%) and 41(29.28%) cases respectively. However, all the reactions were abated 48h and disappeared 72h after immunization. Blood samples were collected from 100 of the 140 person before and 1 month after immunization and detected for the titers of 23 kinds of antibodies by improved ELISA.The result showed that the GMT of total antibody of them increased by 2.4 folds. Significant differences were observed in the titers of all the antibodies except for type 3 before and after immunization. It showed good immunogenicity of the vaccine.