Immunogenicity and safety of Intanza®/IDflu® intradermal influenza vaccine in South Korean adults
Immunogenicity and safety of Intanza®/IDflu® intradermal influenza vaccine in South Korean adults
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DOI：
10.4161/hv.25295
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发表时间：
2013-09-01
影响因子：
4.8
通讯作者：
Kim, June Myung
中科院分区：
文献类型：
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作者：
Han, Sang Hoon;Woo, Jun Hee;Kim, June Myung
Intanza(注册商标)/IDFlu(注册商标)(法国里昂赛诺菲巴斯德)是一种皮内灭活三价流感疫苗，是作为肌肉注射流感疫苗的替代品而开发的。这项研究的目的是证实Intanza/IDFlu在韩国成年人中的免疫原性和安全性。在第四阶段多中心试验中，韩国18-59岁的成年人(n=120)和60岁的成年人(n=120)被随机分为两组，分别接受单剂Intanza/IDFlu(18-59岁9毫克，60岁15微克)或三价肌肉注射疫苗(法国里昂赛诺菲巴斯德公司的Vaxigrip(R)15微克)。分别于接种前(第0天)和第21天采血。第21天测定血凝抑制效价、血清保护率和血清转换率。两个年龄组的皮内和肌肉内疫苗对所有三种疫苗毒株(A/H1N1、A/H3N2和B)的几何平均滴度、血清保护率和血清转换率相似。这两种疫苗都符合人类用药品委员会对所有三种毒株的标准。皮内注射组的全身反应一般轻微、短暂，与肌肉注射组相似。皮内注射部位反应在皮内注射组中更为常见，但大多是轻微的、一过性的，主要包括疼痛、红斑和瘙痒。没有与治疗相关的严重不良事件或其他安全问题的报告。这些结果证实Intanza/IDFlu是IM流感疫苗的有效和耐受性良好的替代品。(ClinicalTrials.gov NCT ID：NCT01215669)
Intanza((R))/IDflu((R)) (Sanofi Pasteur, Lyon, France) is an intradermal inactivated trivalent influenza vaccine developed as an alternative to intramuscular influenza vaccine. The objective of this study was to confirm the immunogenicity and safety of Intanza/IDflu in South Korean adults. In a phase IV multicenter trial, South Korean adults 18-59 y old (n = 120) and 60 y old (n = 120) were randomized 1:1 to receive a single dose of Intanza/IDflu (9 mu g for 18-59 y, 15 mu g for 60 y) or trivalent intramuscular vaccine (Vaxigrip((R)) 15 mu g, Sanofi Pasteur, Lyon, France). Blood was collected on pre-vaccination (day 0) and on day 21. Hemagglutination inhibition titers, seroprotection rates and seroconversion rates were determined on day 21. Geometric mean titers, seroprotection and seroconversion rates were similar between the intradermal and intramuscular vaccines in both age groups for all three vaccine strains (A/H1N1, A/H3N2 and B). Both vaccines met Committee for Medicinal Products for Human Use criteria for all three strains. Solicited systemic reactions of the intradermal groups were generally mild, transient, and similar to those of the intramuscular groups. Solicited injection site reactions were more frequent in the intradermal groups but were mostly mild, transient, and consisted mainly of pain, erythema, and pruritus. No treatment-related serious adverse events or other safety concerns were reported. These results confirm that Intanza/IDflu is an effective and well-tolerated alternative to IM influenza vaccination. (Clinicaltrials.gov NCT ID: NCT01215669)