甲型H1N1流感病毒裂解疫苗的免疫原性和安全性

发布时间：2018-01-28 20:05

本文关键词： 甲型HN流感病毒疫苗临床试验安全性免疫原性　出处：《微生物学免疫学进展》2015年05期 　论文类型：期刊论文

【摘要】：目的评价甲型H1N1流感病毒裂解疫苗(简称甲型H1N1流感疫苗)的免疫原性和安全性。方法按照随机、双盲、安慰剂对照的原则,采用0、21天免疫程序,选择3岁及3岁以上健康者1 202人。分组为3~11岁、12~17岁、≥60岁组,按照人数基本为1∶1的比例随机分别接种7.5μg和15.0μg甲型H1N1流感疫苗;18~59岁组按照人数基本为1∶1∶1的比例随机分别接种7.5μg、15.0μg甲型H1N1流感疫苗和安慰剂对照。观察各组接种后的不良反应率以及免疫前后血凝抑制(HI)抗体阳转率、保护率、GMT水平和平均增长倍数。结果受试对象的安全性结果显示7.5μg和15.0μg组不良反应发生率分别为8.74%(48/549)和13.88%(74/533),其中Ⅱ级反应率分别为0.36%(2/549)和1.13%(6/533),未观察到Ⅲ级及以上不良反应和其他异常反应及严重不良事件。2剂接种未见不良反应叠加现象。7.5μg或15.0μg试验疫苗首剂免疫后,血清抗体阳性率分别为85.13%(395/464)和90.77%(413/455),保护率分别为85.56%(397/464)和91.43%(416/455),抗体GMT较免疫前分别增长36.1倍和52.6倍。2剂免疫后,血清抗体阳性率分别是97.84%(454/464)和99.12%(451/455),保护率分别是98.06%(455/464)和9 9.56%(453/455),抗体GMT较免疫前分别增长63.3倍和96.0倍。4个年龄组(3~11岁、12~17岁、18~59岁及≥60岁年龄组)7.5μg和15.0μg组HI抗体阳性率和保护率均大于70%,GMT较免疫前均增长2.5倍以上,结果显示7.5μg和15.0μg甲型H1N1流感疫苗接种1剂后抗体水平已达到研究方案中设定的预期标准,免疫2剂后抗体阳性率和抗体水平明显提高。结论临床试验表明甲型H1N1流感疫苗具有良好的安全性和免疫原性,且接种1剂15.0μg甲型H1N1流感疫苗,即可在3岁和3岁以上人群中产生良好的免疫效果。
[Abstract]:Objective to evaluate a H1N1 Influenza Split Vaccine (referred to as H1N1 influenza vaccine) immunogenicity and safety. Methods a randomized, double-blind, placebo-controlled principle, using 0,21 days of immunization program, 3 years old and over 3 years old and 1202 healthy people. The group is 3~11 years old, 12 year old ~17, aged 60 years old group. According to the number of basic 1: 1 ratio were inoculated with 7.5 g and 15 g H1N1 influenza vaccine; 18~59 age group according to the number of basic 1: 1: 1 ratio were inoculated with 7.5 g, 15 g H1N1 influenza vaccine and placebo control. To observe the rate of adverse reaction in each group after inoculation and before and after immune hemagglutination inhibition (HI) antibody positive conversion rate, rate of protection, the level of GMT and the average growth rate. The results showed that 7.5 security subjects g and 15 in group G, the incidence of adverse reaction were 8.74% (48/549) and 13.88% (74/533), the reaction rate of grade II Were 0.36% (2/549) and 1.13% (6/533), was not observed in class III and above adverse reactions and other abnormal reactions and serious adverse events.2 dose no adverse reactions.7.5 superposition phenomenon g or 15 g after the first dose of vaccine immunization, the antibody positive rate was 85.13% (395/464) and 90.77% (413/455), the protection rate was 85.56% (397/464) and 91.43% (416/455), GMT antibody before immunization increased 36.1 times and 52.6 times of.2 after immunization, the antibody positive rate was 97.84% (454/464) and 99.12% (451/455), the protection rate was 98.06% (455/464) and 99.56% (453/455). GMT antibody before immunization increased 63.3 times and 96 times the.4 age group (3~11 years, 12~17 years, 18~59 years and over 60 age group) 7.5 g and 15 HI antibody positive rate of G group and the protection rate was greater than 70% GMT before immunization were increased more than 2.5 times, the results showed that 7.5 g and 15 g / H1N1 The antibody level 1 agent after influenza vaccination has reached the expected standard setting scheme of the immune after 2 agents antibody positive rate and antibody levels were significantly increased. Conclusion the clinical trials indicated that H1N1 influenza vaccine has good safety and immunogenicity, and vaccination with 1 doses of 15 g influenza a H1N1 influenza vaccine can produce immune good effect at the age of 3 and 3 years of age or older.

【作者单位】：内蒙古自治区疾病预防控制中心;兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心;赤峰市疾病预防控制中心;长春生物制品研究所有限责任公司;
【分类号】：R392
【正文快照】： 流感病毒是一种造成人类及动物患流行性感冒的RNA病毒,流感病毒属于正粘病毒科,它会造成急性上呼吸道感染,并借由空气迅速传播[1]。人流感病毒分为甲(A)、乙(B)、丙(C)三型,是流行性感冒(流感)的病原体。其中甲型流感病毒抗原性易发生变异,多次引起世界性大流行[2]。在人群中

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