Superior immunogenicity profile of the new intradermal influenza vaccine compared to the standard subcutaneous vaccine in subjects 65 years and older: A randomized controlled phase III study
Superior immunogenicity profile of the new intradermal influenza vaccine compared to the standard subcutaneous vaccine in subjects 65 years and older: A randomized controlled phase III study
复制标题
DOI：
10.1016/j.vaccine.2015.10.088
复制
发表时间：
2015-11-27
期刊：
影响因子：
5.5
通讯作者：
Takeshita, Fumihiko
中科院分区：
文献类型：
--
作者：
Arakane, Ryo;Annaka, Ryosuke;Takeshita, Fumihiko
背景：虽然老年人是流感的高危人群，但老年人的免疫原性低于年轻人。我们研制了一种新型的季节性流感疫苗，该疫苗采用了新型的皮内注射系统。在之前的探索性阶段研究中，ID疫苗（每株15 μ g HA）的剂量在20岁及以上受试者中显示出优于标准皮下（SC）注射疫苗的免疫原性特征。在这项多中心、随机、双盲、活性对照研究中，将900名65岁及以上的成年人以相同比例随机分配至ID疫苗组或许可的标准SC疫苗组。使用血清血凝抑制（HAI）滴度评估免疫原性。协同主要终点为第21天（接种后21天）针对3种疫苗株的HAI滴度的几何平均滴度（GMT）和血清转换率（SCR）。为了评估早期免疫原性，还以与次要终点相同的方式评估了第7天的GMT和SCR。结果：在第7天和第21天，所有3种疫苗株均证明了ID疫苗在GMT和SCR方面的优效性。任何注射部位反应的频率在ID疫苗组中更高，而注射部位反应的严重程度和全身AE的频率在ID和SC疫苗组之间相当。只有一个-建议使用新型ID注射系统和15 μ g HA剂量的流感疫苗作为流感预防和相关疾病的临床应用的适当方案减负。从免疫原性和安全性的角度来看，新的ID疫苗有可能取代标准流感疫苗。试验注册：日本临床试验信息（JapicCTI-142493）。(C)2015作者由爱思唯尔有限公司发布
Background: Although the elderly are at high risk for influenza, the immunogenicity in the elderly is lower than that in younger adults. We developed the new type of seasonal influenza vaccine with the novel intradermal (ID) injection system. In the previous exploratory phase study of the ID vaccine with a dose of 15 mu g HA per strain showed the superior immunogenicity profile to that of the standard subcutaneous (SC) injection vaccine in subjects aged 20 years and older.Methods: In this multicenter, randomized, double-blind, active controlled study, 900 adults aged 65 years and older were randomized at an equal ratio to either the ID vaccine group or the licensed standard SC vaccine group. Immunogenicity was assessed using serum hemagglutination inhibition (HAI) titers. The co-primary endpoints were the geometrical mean titers (GMT) and the seroconversion rates (SCR) of HAI titers against 3 vaccine strains on Day 21 (21 days after vaccination). To evaluate the early phase immunogenicity, the GMTs and SCRs on Day 7 were also assessed in the same way as the secondary endpoints.Results: The superiority of the ID vaccine in the GMTs and SCRs were demonstrated in all 3 vaccine strains both on Day 7 and Day 21. The frequency of any injection-site reactions was higher in the ID vaccine group, while the severity of injection-site reactions and the frequency of systemic AEs were comparable between the ID and the SC vaccine groups.Conclusions: A single-dose of the influenza vaccine with the novel ID injection system and a dose of 15 mu g HA was suggested as an appropriate regimen for clinical use in influenza prevention and associated disease burden reduction. It was also suggested that the new ID vaccine has the potential to replace the standard influenza vaccine from the view point of immunogenicity and safety. Trial registration: JAPIC Clinical Trials Information (JapicCTI-142493). (C) 2015 The Authors. Published by Elsevier Ltd.