التفاصيل البيبلوغرافية
| العنوان: |
Three-dose versus four-dose primary schedules for tick-borne encephalitis (TBE) vaccine FSME-immun for those aged 50 years or older : A single-centre, open-label, randomized controlled trial |
| المؤلفون: |
Kantele, Anu, Rombo, Lars, Vene, Sirkka, Kundi, Michael, Lindquist, Lars, Erra, Elina O. |
| المساهمون: |
Department of Medicine, HUS Inflammation Center, HUMI - Human Microbiome Research, Infektiosairauksien yksikkö |
| بيانات النشر: |
ELSEVIER SCI IRELAND LTD |
| سنة النشر: |
2022 |
| المجموعة: |
Helsingfors Universitet: HELDA – Helsingin yliopiston digitaalinen arkisto |
| مصطلحات موضوعية: |
Tick -borne encephalitis, TBE, Middle-aged, Vector -borne, Central nervous system, TBE virus, TBE vaccination, TBE vaccine, BOOSTER VACCINATION, 0.5 ML, SAFETY, ADULTS, IMMUNOGENICITY, PERSISTENCE, ANTIBODIES, SEROPERSISTENCE, FSME-IMMUN(R), 3111 Biomedicine, 3121 General medicine, internal medicine and other clinical medicine |
| الوصف: |
Background: 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. Methods: 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 neu-tralizing 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. Results: 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). Conclusion: 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. (c) 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/). ; Peer reviewed |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| العلاقة: |
This work was supported by Baxter, the Finnish Governmental Subsidy for Health Science Research, and Finska Lakaresallskapet. The vaccines were provided by Baxter. Serological analyses of blinded samples were conducted by Baxter in 2012. At that time, Baxter was the manufacturer and marketing authorization holder of FSME-Immun. Apart from that described above, the funding sources had no role in study design, data collection, data interpretation, writing of the report, or the decision to submit the article for publication. The corresponding author had full access to all the study data and ultimate responsibility for the decision to submit for publication.; Kantele , A , Rombo , L , Vene , S , Kundi , M , Lindquist , L & Erra , E O 2022 , ' Three-dose versus four-dose primary schedules for tick-borne encephalitis (TBE) vaccine FSME-immun for those aged 50 years or older : A single-centre, open-label, randomized controlled trial ' , Vaccine , vol. 40 , no. 9 , pp. 1299-1305 . https://doi.org/10.1016/j.vaccine.2022.01.022Test; ed3cb217-01fd-4f05-bd6e-5597720765ba; http://hdl.handle.net/10138/342601Test; 000760201300016 |
| الإتاحة: |
http://hdl.handle.net/10138/342601Test |
| حقوق: |
cc_by ; openAccess ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: |
edsbas.C07FFD6C |
| قاعدة البيانات: |
BASE |
