台湾老年人中高剂量四价流感疫苗的免疫原性和安全性：一项 III 期、随机、多中心研究。
Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study.
机构信息
Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan; Chang Gung University College of Medicine, Taoyuan, Taiwan.
National Taiwan University Hospital, Taipei, Taiwan.
出版信息
Vaccine. 2022 Oct 26;40(45):6450-6454. doi: 10.1016/j.vaccine.2022.09.078. Epub 2022 Oct 7.
BACKGROUND
High-dose influenza vaccine offers better protection against influenza/associated complications compared with standard-dose formulation. We evaluated immunogenicity and safety of high-dose influenza vaccine (QIV-HD) and standard-dose (QIV-SD) in older adults (≥ 65 years) in Taiwan.
METHODS
This was a phase III, randomized, modified double-blind, active-controlled, multi-center, descriptive study in older adults. Participants (N = 165) were randomized 1:1 to receive QIV-HD or QIV-SD vaccine (clinicaltrials.gov#NCT04537234).
RESULTS
For all four influenza strains, geometric means titers (GMTs) of hemagglutination inhibition were higher for the QIV-HD than QIV-SD with adjusted GMT ratios (95 % CI) of 2.65 (1.87-3.75) for A/H1N1; 1.76 (1.31-2.38) for A/H3N2; 2.60 (1.90-3.56) for B/Victoria; and 2.01 (1.57-2.56) for B/Yamagata. The seroconversion was higher for QIV-HD than QIV-SD with similar safety profiles across both groups.
CONCLUSION
QIV-HD was highly immunogenic for four influenza strains and have acceptable safety profile in older adults aged ≥ 65 years in Taiwan.
背景
与标准剂量相比，高剂量流感疫苗能更好地预防流感/相关并发症。我们评估了高剂量流感疫苗（QIV-HD）和标准剂量（QIV-SD）在台湾老年人群（≥65 岁）中的免疫原性和安全性。
方法
这是一项在≥65 岁老年人群中进行的 III 期、随机、改良双盲、活性对照、多中心、描述性研究。参与者（N=165）按 1:1 随机接受 QIV-HD 或 QIV-SD 疫苗（clinicaltrials.gov#NCT04537234）。
结果
对于所有四种流感毒株，血凝抑制的几何平均滴度（GMT）均高于 QIV-SD，调整后的 GMT 比值（95%CI）为 A/H1N1 为 2.65（1.87-3.75）；A/H3N2 为 1.76（1.31-2.38）；B/Victoria 为 2.60（1.90-3.56）；B/Yamagata 为 2.01（1.57-2.56）。QIV-HD 的血清转化率高于 QIV-SD，两组的安全性相似。
结论
QIV-HD 对四种流感株高度免疫原性，在台湾≥65 岁的老年人群中具有可接受的安全性。
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