7价肺炎球菌结合疫苗(沛儿TM)用于健康中国儿童加强免疫的安全性和免疫原性  

Safety and Immunogenicity of a 7-valent Pneumococcal Conjugate Vaccine (Prevenar^(TM)) Booster Dose in Healthy Chinese Toddlers

作　　者：李荣成[1] 李凤祥[2] 李艳萍[1] 郭素英[3] 农艺[1] 叶强[2] 方孔雄[3] 韦少超[3] Jay Graepel Mariano Young 

机构地区：[1]广西壮族自治区疾病预防控制中心,南宁530028 [2]中国药品生物制品检定所,北京100050 [3]隆安县疾病预防控制中心,广西壮族自治区隆安532700 [4]美国惠氏全球医学事务,Collegeville PA 19426 [5]惠氏制药有限公司,上海200041

出　　处：《中国疫苗和免疫》2009年第3期196-200,共5页Chinese Journal of Vaccines and Immunization

摘　　要：目的评价已接种3剂7价肺炎球菌结合疫苗(7-Valent Peneumococcal Conjugate Vaccine,PCV7)的健康中国儿童,使用PCV7进行加强免疫的安全性和免疫原性。方法488名中国婴儿在3、4、5月龄接种3剂PCV7后,于12～15月龄时用PCV7加强免疫,接种3剂PCV7的婴儿分为与白喉-破伤风-无细胞百日咳联合疫苗分开接种(第1组)或同时接种(第2组)两组。加强免疫后,对每名受试者进行30d的随访,以观察疫苗的安全性。加强免疫前及加强免疫后30d时,从部分受试者抽取血样,以测定加强免疫的免疫原性。结果PCV7加强免疫后,第1组和第2组分别有89%和91%的受试者体温正常。其局部反应通常为轻度反应。两组受试者每种血清型接种后/接种前抗体几何平均浓度增加的差异均具有非常显著的统计学意义(P<0.0001)。结论PCV7加强免疫对中国健康儿童具有良好的安全性,并能诱发加强免疫应答。Objective To evaluate the safety and immunogenicity of the booster dose of 7 valent pneumococcal conjugate vaccine （PCV7） to the healthy Chinese toddlers who had received 3 primary doses. Methods Four hundred and eighty-eight Chinese toddlers received a booster dose of PCV7 at age of 12-15 months following a primary series of the vaccine given at ages 3, 4, 5 months separately with Diphtheria Tetanus Acellular Pertussis Combined Vaccine （DTaP） in Group 1 or concurrently with DTaP in Group 2. Following the booster dose immunization, each subject was followed up for 30 days to observe the safety of the vaccine. Blood samples were taken from a subset of subjects prior and post 30 days the booster dose immtmization to evaluate immunogenicity. Results A high proportion of subjects in Group 1 （89%） and Group 2 （91%） remained afebrile after the booster dose. Local reactions to the PCV7 booster dose were generally mild. For each serotype, the rise in GMC （post-/pre-vaccination） showed a statistically significant difference （P〈0.0001） between both groups. Conclusion PCV7 administered as a booster dose is generally safe, well tolerate, and immunogenic in healthy Chinese toddlers.

关 键 词：7价肺炎球菌结合疫苗 加强免疫 安全性 免疫原性 

分 类 号：R186[医药卫生—流行病学] R515[医药卫生—公共卫生与预防医学]