摘要
目的评价冻干A群C群脑膜炎球菌多糖结合疫苗在3~8月龄健康婴幼儿人群中的免疫原性和安全性。方法采用随机、盲法、对照设计,在广西全州县选择3~8月龄健康婴幼儿300人,按照1∶1分别随机进入试验组和对照组,对照组接种已上市A群C群脑膜炎球菌多糖结合疫苗,试验组接种冻干A群C群脑膜炎球菌多糖结合疫苗。分别于免疫前和全程免疫后30 d采集静脉血,检测血清中抗A、C群流脑抗体滴度,并计算阳转率(4倍增长)。观察并记录每针次疫苗接种后30 min、6~8 h、24 h、48 h、72 h^7 d的不良反应,并随访30 d。结果 261名受试者完成免疫原性观察,对照组(132人)和试验组(129人)A群、C群抗体阳转率分别为93. 94%、96. 90%和97. 73%、98. 45%,试验组与对照组率差为2. 96%(-2. 09%,∞)和0. 72%(-2. 60%,∞);A群和C群免疫后抗体GMT分别为134. 90、163. 89和152. 22、154. 48,组间比较差异均无统计学意义(P均> 0. 05)。300名受试者均进入安全性分析集,对照组(150人)和试验组(150人)全身反应发生率分别为50. 00%和56. 67%,局部反应发生率分别为6. 00%和3. 33%,组间比较差异均无统计学意义(P均> 0. 05)。结论冻干A群C群脑膜炎球菌多糖结合疫苗在3~8月龄健康婴幼儿人群中具有良好的免疫原性和安全性。
Objective To evaluate the immunogenicity and safety of groups A and C meningococcal polysaccharide conjugate vaccine in healthy infants at ages of 3 ~ 8 months. Methods A randomized,double-blinded and controlled clinical trial was carried out among 300 infants at ages of 3 ~ 8 months in Quanzhou County,Guangxi Zhuang Autonomous Region,China. The infants were randomly divided into trial and control groups according to a ratio of 1 ∶ 1. The infants in trial group were immunized with freeze-dried groups A and C meningococcal polysaccharide conjugate vaccine,while those in control groups with a commercial product of same kind. Serum samples were collected before and 30 d after fullcourse immunization and determined for antibody titers against groups A and C meningococci,based on which the antibody positive seroconversion rate(4-fold increasing rate of titer)was calculated. The adverse reactions 30 min,6 ~ 8 h,24 h,48 h and 72 h ~ 7 d after each dose were observed and followed up for 30 d. Results A total of 261 infants were involved in the trial for immunogenicity,including 132 ones in control group and 129 ones in trial group. The antibody positive seroconversion rates against groups A and C meningococci in control group were 93. 94% and 96. 90%,while those in trial group were 97. 73% and 98. 45%,respectively,of which the differences in trial and control groups were2. 96%(-2. 09%,∞) and 0. 72%(-2. 60%,∞) respectively. However,the GMTs of antibodies against groups A and C meningococci in control group were 134. 90 and 163. 89,while those in trial group were 152. 22 and 154. 48,respectively,which showed no significant difference(each P > 0. 05). A total of 300 infants were involved in the trial for safety,including 150 ones in control and 150 ones in trial groups. The systemic reaction rates in control and trial groups were 50. 00% and 56. 67%,while the local reaction rates were 6. 00% and 3. 33%,respectively,which showed no significant difference(each P > 0. 05). Conclusion Freeze-dried groups A and C meningoco
作者
施礼威
梁馨元
李红华
方文建
李亚南
莫兆军
SHI Li-wei;LIANG Xin-yuan;LI Hong-hua;FANG Wen-jian;LI Ya-nan;MO Zhao-jun(Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control,Nanning 530028,Guangxi Zhuang Autonomous Region,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2020年第3期297-301,307,共6页
Chinese Journal of Biologicals
关键词
A群C群脑膜炎球菌多糖结合疫苗
免疫原性
安全性
Groups A and C meningococcal polysaccharide conjugate vaccine
Immunogenicity
Safty
