应用预防医学
應用預防醫學
응용예방의학
JOURNAL OF APPLIED PREVENTIVE MEDICINE
2015年
3期
152-155
,共4页
吴昕%崔雪莲%黎明强%李艳萍%马波%袁琳
吳昕%崔雪蓮%黎明彊%李豔萍%馬波%袁琳
오흔%최설련%려명강%리염평%마파%원림
冻干A+C群脑膜炎球菌多糖结合疫苗%免疫原性%安全性
凍榦A+C群腦膜炎毬菌多糖結閤疫苗%免疫原性%安全性
동간A+C군뇌막염구균다당결합역묘%면역원성%안전성
freeze-dried group A / C meningococcal polysaccharide conjugate vaccine%immunogenicity%safety
目的:评价某新上市国产冻干A+C群脑膜炎球菌多糖结合疫苗接种婴幼儿的安全性和免疫原性。方法采用随机、盲法、对照的方法,选择900名6~23月龄健康儿童,其中6~11月龄300人,12~23月龄600人,每个年龄组按1∶1比例随机分到试验组和对照组。实验组接种某新上市疫苗,对照组接种罗益(无锡)生物制药有限公司生产的同类疫苗。每人接种2剂疫苗,间隔1个月,评价试验组和对照组疫苗免疫后不良反应发生率、抗体阳转率及抗体几何平均滴度(GMT)。结果免疫后两个年龄段A、C群抗体阳转(4倍增长)率均>95%,试验组与对照组的阳转率差异无统计学意义。12~23月龄接种1剂、2剂疫苗后抗体阳转率差异无统计学意义;6~11月龄段,试验组A群抗体水平高于对照组;两个年龄段试验组的C群抗体水平均低于对照组,但均处于较高水平(>1∶128)。实验组与对照组全身及局部不良反应率差异无统计学意义,未观察到与试验疫苗相关的严重不良事件。结论某新上市国产冻干A+C群脑膜炎球菌多糖结合疫苗在6~23月龄的儿童中具有良好安全性和免疫原性。
目的:評價某新上市國產凍榦A+C群腦膜炎毬菌多糖結閤疫苗接種嬰幼兒的安全性和免疫原性。方法採用隨機、盲法、對照的方法,選擇900名6~23月齡健康兒童,其中6~11月齡300人,12~23月齡600人,每箇年齡組按1∶1比例隨機分到試驗組和對照組。實驗組接種某新上市疫苗,對照組接種囉益(無錫)生物製藥有限公司生產的同類疫苗。每人接種2劑疫苗,間隔1箇月,評價試驗組和對照組疫苗免疫後不良反應髮生率、抗體暘轉率及抗體幾何平均滴度(GMT)。結果免疫後兩箇年齡段A、C群抗體暘轉(4倍增長)率均>95%,試驗組與對照組的暘轉率差異無統計學意義。12~23月齡接種1劑、2劑疫苗後抗體暘轉率差異無統計學意義;6~11月齡段,試驗組A群抗體水平高于對照組;兩箇年齡段試驗組的C群抗體水平均低于對照組,但均處于較高水平(>1∶128)。實驗組與對照組全身及跼部不良反應率差異無統計學意義,未觀察到與試驗疫苗相關的嚴重不良事件。結論某新上市國產凍榦A+C群腦膜炎毬菌多糖結閤疫苗在6~23月齡的兒童中具有良好安全性和免疫原性。
목적:평개모신상시국산동간A+C군뇌막염구균다당결합역묘접충영유인적안전성화면역원성。방법채용수궤、맹법、대조적방법,선택900명6~23월령건강인동,기중6~11월령300인,12~23월령600인,매개년령조안1∶1비례수궤분도시험조화대조조。실험조접충모신상시역묘,대조조접충라익(무석)생물제약유한공사생산적동류역묘。매인접충2제역묘,간격1개월,평개시험조화대조조역묘면역후불량반응발생솔、항체양전솔급항체궤하평균적도(GMT)。결과면역후량개년령단A、C군항체양전(4배증장)솔균>95%,시험조여대조조적양전솔차이무통계학의의。12~23월령접충1제、2제역묘후항체양전솔차이무통계학의의;6~11월령단,시험조A군항체수평고우대조조;량개년령단시험조적C군항체수평균저우대조조,단균처우교고수평(>1∶128)。실험조여대조조전신급국부불량반응솔차이무통계학의의,미관찰도여시험역묘상관적엄중불량사건。결론모신상시국산동간A+C군뇌막염구균다당결합역묘재6~23월령적인동중구유량호안전성화면역원성。
Objective To evaluate the safety and immunogenicity of a new home-made vaccine of freeze-dried group A/C meningococcal polysaccharide conjugate (MCV-A/C) in infants. Methods The double-blind, randomized, parallel controlled clinical trial was conducted to evaluate the adverse reaction, the positive conversion rate and GMT of antibodies. The participants included 300 of 6-11 months and 600 of 12-23 months old children, who were randomly allocated to the trial group and control group by age at 1:1 ratio. Each participant was injected with 2 doses of the new brand (in the trial group) or old brand (in the control group) of the vaccine at an interval of 1 month. Results The positive conversion rates of antibodies to A, C antigens were over 95%both in the trial and control group, and there was no significant difference between two groups. In children of 12-23 months the positive conversion rates of antibodies after one injection had no significant difference to that of after the 2 injections. In children of 6-11 months the antibody levels to A were higher in the trial group than in the control group, while those to C at age of 6-23 months were lower in trial group than in the control group, but the titers were over 1:128. There was no serious adverse events reported in the trial vaccine and the systemic or local side effects were similar between the trial and control group. Conclusion The new home made vaccine of freeze-dried group A/C meningococcal polysaccharide conjugate has high safety and immunogenicity in the children at age of 6 -23 months.