中华微生物学和免疫学杂志
中華微生物學和免疫學雜誌
중화미생물학화면역학잡지
CHINESE JOURNAL OF MICROBIOLOGY AND IMMUNOLOGY
2012年
10期
906-910
,共5页
叶强%李亚南%赵志强%李荣成%何莉%谭晓梅%李艳萍%杜送田%李凤祥%谢贵林
葉彊%李亞南%趙誌彊%李榮成%何莉%譚曉梅%李豔萍%杜送田%李鳳祥%謝貴林
협강%리아남%조지강%리영성%하리%담효매%리염평%두송전%리봉상%사귀림
Hib结合疫苗%安全性%免疫原性%抗Hib PRP IgG%几何平均浓度
Hib結閤疫苗%安全性%免疫原性%抗Hib PRP IgG%幾何平均濃度
Hib결합역묘%안전성%면역원성%항Hib PRP IgG%궤하평균농도
Hib-TT conjugate vaccine%Safety%Immunogenicity%Anti-Hib PRP IgG%Mean geometric concentration
目的 评价b型流感嗜血杆菌结合疫苗(Hib-TT)安全性和免疫原性.方法 分别采用Hib-TT试验疫苗和对照疫苗3针免疫接种3～5月龄婴幼儿,观察疫苗安全性,并采用定量ELISA法分别测定免疫前、免疫后和加强免疫后血清特异性IgG抗体浓度.结果 实验疫苗和对照疫苗两组间不良反应总发生率(实验疫苗组为23.85％,对照疫苗组为31.40％)差异无统计学意义(x2=0.5,P＞0.05),发热性总不良反应率分别为22.3％和31.3％,中、强发热反应率分别为3.67％和4.48％,差异无统计学意义；实验疫苗受试者局部红、肿、硬结等不良反应率为1.22％.实验疫苗3剂免疫后受试者血清抗Hib PRP IgG抗体平均几何浓度(GMC)为6.6786 μg/ml,对照疫苗组血清抗体GMC为7.5346 μg/ml,两组间抗体GMC差异无统计学意义(x2=0.147,P=0.702)；加强免疫1剂后,实验疫苗组受试者血清抗体GMC从加强免疫前的2.6396 μg/ml上升为6.2044μg/ml.结论 实验疫苗接种3～5月龄婴幼儿具有良好的安全性.用间隔1个月、3剂次接种的基础免疫程序能诱导该年龄组受试者产生长期保护水平的血清特异性抗体,加强免疫1剂后能诱导机体产生免疫记忆反应.
目的 評價b型流感嗜血桿菌結閤疫苗(Hib-TT)安全性和免疫原性.方法 分彆採用Hib-TT試驗疫苗和對照疫苗3針免疫接種3～5月齡嬰幼兒,觀察疫苗安全性,併採用定量ELISA法分彆測定免疫前、免疫後和加彊免疫後血清特異性IgG抗體濃度.結果 實驗疫苗和對照疫苗兩組間不良反應總髮生率(實驗疫苗組為23.85％,對照疫苗組為31.40％)差異無統計學意義(x2=0.5,P＞0.05),髮熱性總不良反應率分彆為22.3％和31.3％,中、彊髮熱反應率分彆為3.67％和4.48％,差異無統計學意義；實驗疫苗受試者跼部紅、腫、硬結等不良反應率為1.22％.實驗疫苗3劑免疫後受試者血清抗Hib PRP IgG抗體平均幾何濃度(GMC)為6.6786 μg/ml,對照疫苗組血清抗體GMC為7.5346 μg/ml,兩組間抗體GMC差異無統計學意義(x2=0.147,P=0.702)；加彊免疫1劑後,實驗疫苗組受試者血清抗體GMC從加彊免疫前的2.6396 μg/ml上升為6.2044μg/ml.結論 實驗疫苗接種3～5月齡嬰幼兒具有良好的安全性.用間隔1箇月、3劑次接種的基礎免疫程序能誘導該年齡組受試者產生長期保護水平的血清特異性抗體,加彊免疫1劑後能誘導機體產生免疫記憶反應.
목적 평개b형류감기혈간균결합역묘(Hib-TT)안전성화면역원성.방법 분별채용Hib-TT시험역묘화대조역묘3침면역접충3～5월령영유인,관찰역묘안전성,병채용정량ELISA법분별측정면역전、면역후화가강면역후혈청특이성IgG항체농도.결과 실험역묘화대조역묘량조간불량반응총발생솔(실험역묘조위23.85％,대조역묘조위31.40％)차이무통계학의의(x2=0.5,P＞0.05),발열성총불량반응솔분별위22.3％화31.3％,중、강발열반응솔분별위3.67％화4.48％,차이무통계학의의；실험역묘수시자국부홍、종、경결등불량반응솔위1.22％.실험역묘3제면역후수시자혈청항Hib PRP IgG항체평균궤하농도(GMC)위6.6786 μg/ml,대조역묘조혈청항체GMC위7.5346 μg/ml,량조간항체GMC차이무통계학의의(x2=0.147,P=0.702)；가강면역1제후,실험역묘조수시자혈청항체GMC종가강면역전적2.6396 μg/ml상승위6.2044μg/ml.결론 실험역묘접충3～5월령영유인구유량호적안전성.용간격1개월、3제차접충적기출면역정서능유도해년령조수시자산생장기보호수평적혈청특이성항체,가강면역1제후능유도궤체산생면역기억반응.
Objectives To evaluate the safety and immunogenicity of Haemophilus influenzae type b capsular-tetanus toxoid(Hib-TT) conjugate vaccine.Methods In an open-controlled,randomized trial,the eligible and consented infants of 3 to 5 months-old received 3 doses of Hib-TT or a licensed Hib-TT conjugate vaccine(Anerbao) as the control vaccine to evaluate safety; The serum anti-Hib PRP IgG antibody mean geometric concentration (GMC) in both groups after primary and boosting vaccination were measured by ELISA.Results No apparent difference in the frequency of total adverse reactions observed between two groups (study vaccine 23.85％ vs.comparator 31.40％) (x2=0.5,P＞0.05).The mild and severe fever reaction of both vaccines was 3.67％ and 4.48％ respectively,with no significant difference.The local reactions including erythema,swelling and induration reported was 1.22％ in study vaccine group.After 3 injections,the serum anti-Hib PRP IgG antibody GMC was 6.6686 μg/ml in study group and 7.5346 μg/ml in control group,with no significant difference in both of the antibody GMC (x2 =0.147,P=0.702).After one dose boosting injection,the serum antibody GMC in study group increased from 2.6396 μg/ml of preboosting to 6.2044 μg/ml of post-boosting.Conclusion The Hib-TT conjugate vaccine is proved to be safe in 3-5 months-old infants.The primary immune schedule for 3-5 months-old infants of 3 injections 1 month apart with the Hib-TT conjugate vaccine could induce IgG antibody response against Hib PRP with the GMC of long-term protection concentration in serum.A boosting dose after primary vaccination elicited obviously immunological memory.
