摘要
目的评价某公司生产的四价流感病毒裂解疫苗(四价流感疫苗)安全性和免疫原性。方法选择河南省舞阳县和西平县≥3岁的健康人群为研究对象,按照1∶1∶1随机纳入试验组、对照1组和对照2组,分别接种四价流感疫苗、三价流感疫苗(不含Bv型)和三价流感疫苗(不含By型);检测接种前后血凝抑制(HI)抗体滴度,分析接种后疑似预防接种异常反应(AEFI)发生率、HI抗体阳转率、HI抗体保护率和几何平均滴度(GMT)增长倍数,并与欧盟和美国食品药品管理局(FDA)制定的流感疫苗质量标准(HI抗体阳转率>40%、HI抗体保护率>70%和HI抗体GMT增长倍数>2.5)比较。结果纳入2 924人,其中试验组975人,对照1组974人,对照2组975人。接种后30 min~<8 d,试验组AEFI发生率为11.7%,高于对照1组的7.9%和对照2组的8.8%(P<0.05)。试验组H1N1型、H3N2型、By型和Bv型HI抗体阳转率分别为78.5%、53.3%、78.3%和62.9%,试验组与对照2组By型HI抗体阳转率的率差为42.1%(95%CI:38.0%~46.2%),与对照1组Bv型HI抗体阳转率的率差为33.2%(95%CI:28.9%~37.5%),95%CI的下限均>-0.10。试验组、对照1组和对照2组各型HI抗体GMT增长倍数均≥2.5。试验组H1N1型、H3N2型、By型和Bv型HI抗体保护率分别为87.7%、98.7%、93.6%和77.2%,其中By型HI抗体保护率高于对照2组的71.1%(P<0.05),Bv型HI抗体保护率高于对照1组的51.0%(P<0.05)。结论接种某公司四价流感疫苗后,H1N1型、H3N2型、By型和Bv型的HI抗体阳转率、HI抗体保护率和GMT增长倍数均达到欧盟和FDA制定的流感疫苗质量标准,该四价流感疫苗的安全性和免疫原性与同公司的三价流感疫苗(包括不含Bv型、不含By型)处于同一水平。
Objective To evaluate the safety and immunogenicity of a split-virion quadrivalent influenza vaccine.Methods The healthy people aged three years or over in Wuyang County and Xiping County of Henan Province were divided into the experimental group,control group 1 and control group 2,and were vaccinated with split-virion quadrivalent influenza vaccines,split-virion trivalent influenza vaccines(withont B/Victoria) and a split-virion trivalent influenza vaccines(without B/Yamagata),respectively.The hemagglutination inhibition(HI) antibodies were detected before and after immunization.The incidence rate of adverse events following immunization(AEFI),HI antibody positive conversion rate,the protection rate of HI antibodies and the growth of geometric mean titer(GMT) were calculated and compared with the standard of Food and Drug Administration(FDA).Results Totally 2 924 people were recruited,with 975 in the experimental group,974 in the control group 1 and 975 in control group 2.The incidence rate of AEFI in the experimental group was 11.7%,higher than 7.9% in control group 1 and 8.8% in control group 2(P<0.05) during 30 minutes and 8 days after inoculation.The positive conversion rates of HI antibodies of H1N1,H3N2,By and Bv in the experimental group were 78.5%,53.3%,78.3% and 62.9%,respectively.The rate differences of the positive conversion rates of HI antibodies of By between the experimental group and control group 2,and of Bv between the experimental group and control group 1 were 42.1%(95%CI:38.0%-46.2%) and 33.2%(95%CI:28.9%-37.5%),with both lower limits of 95%CI more than-0.10.The GMT increase of HI antibodies was more than 2.5 times in the three groups.The protective rates of HI antibodies of H1N1,H3N2,By and Bv in the experimental group were 87.7%,98.7%,93.6%and 77.2%,respectively.The protective rates of HI antibodies of By in control group 2 and Bv in control group1 were 71.1% and 51.0%,both lower than those in the experimental group(P<0.05).Conclusions After the inoculation of the quadrivalent influenza vaccine,the positive conversion rates(>40%),protection rates(>70%) and GMT increase(>2.5 times) of HI antibodies of H1N1,H3N2,By and Bv all meet the quality standards of FDA.The safety and immunogenicity of the quadrivalent influenza vaccine are not inferior to those of the trivalent influenza vaccine.
作者
刘书珍
孟丽
席佩佩
张勇朝
范蓓
李长贵
夏胜利
潘若文
LIU Shuzhen;MENG Li;XI Peipei;ZHANG Yongchao;FAN Bei;LI Changgui;XIA Shengli;PAN Ruowen(National Institutes for Food and Drug Control,Beijing 102629,China;不详)
出处
《预防医学》
2020年第11期1091-1095,共5页
CHINA PREVENTIVE MEDICINE JOURNAL
关键词
四价流感病毒裂解疫苗
三价流感病毒裂解疫苗
安全性
免疫原性
split-virion quadrivalent influenza vaccine
split-virion trivalent influenza vaccine
safety
immunogenicity
