Efficacy of vaccination with live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine against a variant (A/Sydney) not contained in the vaccine
Efficacy of vaccination with live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine against a variant (A/Sydney) not contained in the vaccine
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DOI：
10.1016/s0022-3476(00)70097-7
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发表时间：
2000-02-01
影响因子：
5.1
通讯作者：
Wolff, M
中科院分区：
文献类型：
--
作者：
Belshe, RB;Gruber, WC;Wolff, M
目的：探讨儿童流感减毒活疫苗复种的安全性、免疫原性和有效性。研究设计：一项为期2年的多中心、双盲、安慰剂对照、效力现场试验，儿童鼻腔喷雾接种三价流感减毒活疫苗。这份报告总结了第二年的结果，在这一年，甲型流感/悉尼流感流行毒株与疫苗毒株没有很好的匹配，每年的疫苗毒株在抗原性上相当于当代灭活流感疫苗。在第二年，只进行了一次鼻内复种。在流感季节，通过病毒培养对流感进行了积极监测。流感病例被定义为从呼吸道分泌物中分离到野生型流感病毒的疾病。结果：在第二年，1358名(85%)年龄在26-85个月的儿童再次接种疫苗。该鼻腔疫苗易于接受，耐受性好，具有免疫原性。在免疫原性研究的子集中，复种导致82%至100%的接种儿童血清阳性，而安慰剂接受者的这一比例为26%至65%，具体取决于所测试的流感毒株。没有与疫苗相关的严重不良事件。除了疫苗中的毒株外，还诱导了对变异株A/悉尼/H3N2的抗体。在第二年，疫苗中没有包含的变种A/悉尼/H3N2导致了70例甲型流感病例中的66例；然而，鼻腔疫苗在预防A/悉尼流感方面的有效率为86%。8例下呼吸道疾病与A/悉尼流感相关；所有病例均为安慰剂组。结论：该疫苗是安全的，具有免疫原性，对甲型H3N2型流感(包括疫苗中未包含的变异型A/悉尼)和B型流感有效。该疫苗的特点使其适合儿童常规使用以预防流感。
Objective: To determine the safety, immunogenicity, and efficacy of revaccination of children with live attenuated influenza vaccine.Study design: A 2-year multicenter, double-blind, placebo-controlled, efficacy field trial of live attenuated, cold-adapted trivalent influenza vaccine administered by nasal spray to children. This report summarizes year 2 results, a year in which the epidemic strain of influenza A/Sydney was not well matched to the vaccine strains, Each year, vaccine strains were antigenically equivalent to the contemporary inactivated influenza vaccine. In year 2, a single intranasal revaccination was administered. Active surveillance for influenza was conducted during the influenza season by means of viral cultures. Influenza cases were defined as illnesses with wild-type influenza virus isolated from respiratory secretions.Results: In year 2, 1358 (85%) children, 26 to 85 months of age, returned for revaccination. The intranasal vaccine was easily accepted, well tolerated, and immunogenic. Revaccination resulted in 82% to 100% of the vaccinated children in a subset studied for immunogenicity being seropositive as compared with 26% to 65% of placebo recipients, depending on the influenza strain tested. No serious adverse events were associated with the vaccine. In addition to the strains in the vaccine, antibody was induced to the variant strain A/Sydney/H3N2. In year 2, influenza A/Sydney/H3N2, a variant not contained in the vaccine, caused 66 of 70 cases of influenza A; nonetheless, intranasal vaccine was 86% efficacious in preventing A/Sydney influenza. Eight cases of lower respiratory tract disease were associated with A/Sydney influenza; all cases were in the placebo group.Conclusions: This live attenuated, cold-adapted influenza vaccine was safe, immunogenic, and efficacious against influenza A/H3N2 (including a variant, A/Sydney, not contained in the vaccine) and influenza B. The characteristics of this vaccine make it suitable for routine use in children to prevent influenza.