23价肺炎球菌多糖疫苗临床试验

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。

Clinical Effect of 23-valent Pneumococcal Polysaccharide Vaccine

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.