Meilahti Vaccine Research Center, MeVac, Department of Infectious Diseases, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Human Microbiome Research Program, Faculty of Medicine, University, University of Helsinki, Helsinki, Finland.
Clinical Research Centre, Sormland County Council Eskilstuna, and University of Uppsala, Uppsala, Sweden; Department of Medical Biochemistry and Microbiology, Zoonosis Science Center, Uppsala University, Uppsala, Sweden.
Vaccine. 2022 Feb 23;40(9):1299-1305. doi: 10.1016/j.vaccine.2022.01.022. Epub 2022 Jan 31.
TBE vaccination failures among those past middle age have raised concern about immune response declining with age. We investigated immunogenicity of the TBE-vaccine FSME-Immun among those aged 50+ years using the standard three-dose primary series and alternative four-dose schedules.
In this single-centre, open-label, randomized controlled trial, 200 TBE-naive Swedish adults were given primary TBE vaccination with FSME-Immun. Those aged 50+ years (n = 150) were randomized to receive the standard three-dose (days 0-30-360) or one of two four-dose series (0-7-21-360; 0-30-90-360). For participants < 50 years (n = 50) the standard three-dose schedule was used. Titres of neutralizing antibodies were determined on days 0, 60, 120, 360, and 400. The main outcome was the log titre of TBE virus-specific neutralizing antibodies on day 400.
The three-dose schedule yielded lower antibody titres among those aged 50+ years than the younger participants on day 400 (geometric mean titre 41 versus 74, p < 0.05). The older group showed higher titres for the four-dose 0-7-21-360 than the standard three-dose schedule both on day 400 (103 versus 41, p < 0.01; primary end point) and at the other testing points (days 60, 120, 360). Using the other four-dose schedule (0-30-90-360), no such difference was observed on day 400 (63 versus 41, NS).
Immune response to the TBE vaccine declined with age. A four-dose schedule (0-7-21-360) may benefit those aged 50 years or older. This study is registered at ClinicalTrials.gov, NCT01361776.
中年以上人群的 TBE 疫苗接种失败引起了人们对随年龄增长免疫反应下降的关注。我们研究了使用标准三剂基础系列和替代四剂方案对 50 岁以上人群进行 TBE 疫苗 FSME-Immun 的免疫原性。
在这项单中心、开放标签、随机对照试验中，200 名 TBE 初免的瑞典成年人接受了 FSME-Immun 的 TBE 初免。50 岁以上（n=150）的人群被随机分配接受标准三剂（第 0、30、360 天）或两种四剂系列中的一种（第 0、7、21、360 天；0、30、90、360 天）。对于<50 岁的参与者（n=50），使用标准三剂方案。在第 0、60、120、360 和 400 天测定中和抗体滴度。主要结局是第 400 天 TBE 病毒特异性中和抗体的对数滴度。
与年轻参与者相比，50 岁以上人群接受三剂方案后的抗体滴度在第 400 天较低（几何平均滴度分别为 41 和 74，p<0.05）。在第 400 天，老年组四剂 0-7-21-360 方案的滴度高于标准三剂方案（103 与 41，p<0.01；主要终点），在其他检测点（第 60、120、360 天）也观察到了这种差异。使用另一种四剂方案（0-30-90-360），在第 400 天未观察到差异（63 与 41，NS）。
TBE 疫苗的免疫反应随年龄增长而下降。四剂方案（0-7-21-360）可能有益于 50 岁或以上人群。本研究在 ClinicalTrials.gov 注册，NCT01361776。
