CAJ | 학술논문

目的评价流感病毒裂解疫苗安尔来福(R)的免疫原性及安全性.方法 2010年8-9月在沈阳市开展开放式临床试验,选择18～60岁及＞60岁健康成年人接种安尔来福(R)进行安全性观察,并采集受试者免疫前及免疫后21 d 血清标本,采用血凝抑制试验(HI)进行流感病毒裂解疫苗甲型H1N1、甲型H3N2及乙型3个型别抗体检测.结果 130名观察对象完成疫苗接种并进行安全性观察,其中120人完成免疫前及免疫后采血.总体不良反应发生率为2.3%(3/130),均为全身不良反应,未出现严重不良反应.接种疫苗后21 d,成年组甲型H1N1、甲型H3N2及乙型3个型别抗体阳转率分别为82.5%、93.7%、92.1%,GMT增长倍数分别为20.2、32.0、11.4,保护率分别为92.1%、98.4%、98.4%;老年组3个型别抗体阳转率分别为89.5%、91.2%、87.7%,GMT增长倍数分别为23.9、39.8、15.1,保护率分别为93.0%、94.7%、96.5%.结论疫苗安尔来福(R)接种后甲型H1N1、甲型H3N2及乙型3个型别抗体各项指标均超过欧盟标准,表明其免疫原性及安全性良好.
목적 평개류감병독렬해역묘안이래복(R)적면역원성급안전성.방법 2010년8-9월재침양시개전개방식림상시험,선택18～60세급＞60세건강성년인접충안이래복(R)진행안전성관찰,병채집수시자면역전급면역후21 d 혈청표본,채용혈응억제시험(HI)진행류감병독렬해역묘갑형H1N1、갑형H3N2급을형3개형별항체검측.결과 130명관찰대상완성역묘접충병진행안전성관찰,기중120인완성면역전급면역후채혈.총체불량반응발생솔위2.3%(3/130),균위전신불량반응,미출현엄중불량반응.접충역묘후21 d,성년조갑형H1N1、갑형H3N2급을형3개형별항체양전솔분별위82.5%、93.7%、92.1%,GMT증장배수분별위20.2、32.0、11.4,보호솔분별위92.1%、98.4%、98.4%;노년조3개형별항체양전솔분별위89.5%、91.2%、87.7%,GMT증장배수분별위23.9、39.8、15.1,보호솔분별위93.0%、94.7%、96.5%.결론 역묘안이래복(R)접충후갑형H1N1、갑형H3N2급을형3개형별항체각항지표균초과구맹표준,표명기면역원성급안전성량호.
Objective To evaluate the safety and immunogenicity of split influenza vaccine (Anflu(R) ). Methods An open-labeled clinical trial was carried out in adults aged 18-60 years and elders aged over 60 years from August to September, 2010 in Shenyang, Liaoning province. One dose of split influenza vaccine was administered and adverse events were observed. Serum samples were obtained prior to vaccination and 21 days post vaccination. A/H1N1, A/H3N2 and B antibodies against influenza virus were measured using micro-hemagglutination inhibition (HI) assay. Results A total of 130 subjects were recruited and 120 paired serum samples were obtained. The overall rate of adverse events was 2.3% (3/130) and all of them with systemic reaction. No single serious adverse event was reported. 21 days after the vaccination, the sero-conversion rates of A/H1N1, A/H3N2 and B antibodies against influenza virus among adults were 82.5%, 93.7% and 92.1%, respectively. The Geometric Mean Titer (GMT) ratios were 20.2, 32.0 and 11.4, while the sero-protection rates were 92.1%, 98.4% and 98.4%, respectively. The sero-conversion rates of antibodies among elders were 89.5%, 91.2% and 87.7%, with the GMT ratios as 23.9, 39.8 and 15.1, respectively. The seroprotection rates were 93.0%, 94.7% and 96.5%,respectively. Conclusion All indexes ofA/H1N1,A/H3N2 and B antibodies exceeded the licensure criteria established by the EU Committee for Medicinal Products for Human Use,proving the trial vaccine Anflu(R) with good safety and immunogenicity.