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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 PCV7 for boiled Chinese children who have been vaccinated with 7 doses of 7-valent pneumococcal conjugate vaccine (PCV7). Methods 488 Chinese infants were boosted with PCV7 at 12-15 months of age after vaccination with 3 doses of PCV7 at 3, 4, and 5 months of age. Infants vaccinated with 3 doses of PCV7 were divided into diphtheria-tetanus-acellular pertussis vaccine The two groups were inoculated separately (group 1) or at the same time (group 2). After booster immunization, each subject was followed for 30 days to observe the safety of the vaccine. At 30 days before and after booster immunization, blood samples were drawn from some subjects to determine the immunogenicity of the booster immunization. Results After PCV7 booster immunization, 89% and 91% of subjects in groups 1 and 2, respectively, had normal body temperature. The local reaction is usually a mild reaction. The differences in the geometric mean concentrations of antibodies after vaccination / inoculation of each serogroup in both groups were statistically significant (P <0.0001). Conclusions PCV7 boosted immunity has good safety for Chinese healthy children and can induce enhanced immune response.