CAJ | 학술논문

目的评价季节性流感裂解疫苗(安尔来福(R))的免疫原性及安全性,分析与H7N9禽流感病毒的交叉免疫反应.方法采用临床研究开放式设计,选择6 ～ 35月龄婴幼儿(免疫接种方式:2针,0、28 d)、18～ 60岁成年人及＞60岁老年人(1针)接种安尔来福(R).所有接种者免疫后均接受安全性观察,并采集成年人和老年人免疫前后21d的血清标本,利用血凝抑制试验(HI)检测疫苗3种(甲型流感2种和乙型流感1种)病毒株以及H7N9禽流感病毒抗体.采用欧盟流感疫苗临床研究标准(欧盟标准)评价疫苗免疫效果.结果共202(婴幼儿65、成年人69及老年人68)人完成接种和安全性观察.不良反应发生率为12.4％(25/202),以全身不良反应为主,未见严重不良反应.有124(成年人64、老年人60)人采集到免疫前后配对血清.接种疫苗后21d,成年组3个型别HI抗体阳转率为78.1％～ 90.6％,抗体保护率为92.2％～ 100.0％,GMT增长7.9～41.0倍;老年组HI抗体阳转率为66.7％～ 83.3％,抗体保护率为86.7％～ 100.0％,GMT增长5.7 ～ 20.4倍.均达到欧盟标准.而接种疫苗后,成年组和老年组抗H7N9抗体阳性率和阳转率仍保持为零,GMT增长仅1.2～1.4倍.结论季节性灭活流感裂解疫苗的安全性和免疫原性良好,但对H7N9禽流感病毒无交叉免疫反应.
목적 평개계절성류감렬해역묘(안이래복(R))적면역원성급안전성,분석여H7N9금류감병독적교차면역반응.방법 채용림상연구개방식설계,선택6 ～ 35월령영유인(면역접충방식:2침,0、28 d)、18～ 60세성년인급＞60세노년인(1침)접충안이래복(R).소유접충자면역후균접수안전성관찰,병채집성년인화노년인면역전후21d적혈청표본,이용혈응억제시험(HI)검측역묘3충(갑형류감2충화을형류감1충)병독주이급H7N9금류감병독항체.채용구맹류감역묘림상연구표준(구맹표준)평개역묘면역효과.결과 공202(영유인65、성년인69급노년인68)인완성접충화안전성관찰.불량반응발생솔위12.4％(25/202),이전신불량반응위주,미견엄중불량반응.유124(성년인64、노년인60)인채집도면역전후배대혈청.접충역묘후21d,성년조3개형별HI항체양전솔위78.1％～ 90.6％,항체보호솔위92.2％～ 100.0％,GMT증장7.9～41.0배;노년조HI항체양전솔위66.7％～ 83.3％,항체보호솔위86.7％～ 100.0％,GMT증장5.7 ～ 20.4배.균체도구맹표준.이접충역묘후,성년조화노년조항H7N9항체양성솔화양전솔잉보지위령,GMT증장부1.2～1.4배.결론 계절성멸활류감렬해역묘적안전성화면역원성량호,단대H7N9금류감병독무교차면역반응.
Objective To evaluate the safety and immunogenicity of seasonal inactivated influenza vaccine (split virion)and to analyze its cross-reactive antibody responses to H7N9 avian influenza virus.Methods An open-labeled clinical trial was carried out in infants aged 6-35 months,adults aged 18-60 years and the elderly aged ＞60 years.After vaccinations (one dose for adults and the elderly and two doses for infants),adverse events were observed.Serum samples were obtained before vaccination and 21 days after vaccination from adults and elderly subjects.Three types of antibody against seasonal influenza virus and antibody against H7N9 avian influenza virus were tested using microhemagglutination inhibition (HI) assay.Immunogenicity of the vaccine was evaluated based on the immunogenicity criteria for adults and the elderly,set by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency.Results A total of 202 subjects (65 infants,69 adults and 68 elderly) were enrolled and injected for at least one dose.The overall rate of adverse events was 12.4％ (25/202) and most of them were under systemic reaction.No serious adverse event was reported.Pre-and post-vaccination serum samples were collected from 124 subjects (64 adults,60 elderly).After 21 days of vaccination,the sero-conversion rate,sero-protection rate,and geometric mean titer (GMT) ratio (post-/pre-vaccination) of antibody against seasonal influenza virus were 78.1％-90.6％,92.2％-100.0％ and 7.9-41.0 among adults while 66.7％-83.3％,86.7％-100.0％ and 5.7-20.4 among the elderly,respectively.However,after vaccination,both sero-conversion rate and sero-protection rate of antibody against HTN9 avian influenza vires among adults and the elderly became zero,with GMT ratio between 1.2 and 1.4.Conclusion This trial vaccine appeared to have good safety and immunogenicity but inducing no cross-reactive antibody response to H7N9 avian influenza virus.