Primary TBE Vaccination for the Elderly
Summary
Tick-borne Encephalitis (TBE) can be prevented by vaccine. Vaccine failure, defined as a case of TBE regardless of previous vaccination, has been described and seems to be more predominant with increasing age, suggesting a less effective immune response following with increasing age. In fact previous studies has shown a reduced antibody response in elderly individuals compared to younger when vaccinated against TBE. As a result, in Sweden, an extra vaccine dose has been recommended during the primary vaccine schedule to individuals \> 50 years of age. This alternative vaccine schedule has not been tested. The investigator aim to test if an extra vaccine dose in the primary vaccine schedule for those \> 50 years of age improves the immune response and offers a corresponding immunity to younger individuals following TBE vaccination.
Timeline
- Start
- 2024-01
- Primary completion
- 2024-01
- Completion
- 2025-01
Publications
- Background Lindquist L, Vapalahti O. Tick-borne encephalitis. Lancet. 2008 May 31;371(9627):1861-71. doi: 10.1016/S0140-6736(08)60800-4.
- Background Prymula R, Pollabauer EM, Pavlova BG, Low-Baselli A, Fritsch S, Angermayr R, Geisberger A, Barrett PN, Ehrlich HJ. Antibody persistence after two vaccinations with either FSME-IMMUN(R) Junior or ENCEPUR(R) Children followed by third vaccination with FSME-IMMUN(R) Junior. Hum Vaccin Immunother. 2012 Jun;8(6):736-42. doi: 10.4161/hv.20058. Epub 2012 Jun 1.
- Background Jilkova E, Vejvalkova P, Stiborova I, Skorkovsky J, Kral V. Serological response to tick-borne encephalitis (TBE) vaccination in the elderly--results from an observational study. Expert Opin Biol Ther. 2009 Jul;9(7):797-803. doi: 10.1517/14712590903066711.
- Background Hainz U, Jenewein B, Asch E, Pfeiffer KP, Berger P, Grubeck-Loebenstein B. Insufficient protection for healthy elderly adults by tetanus and TBE vaccines. Vaccine. 2005 May 9;23(25):3232-5. doi: 10.1016/j.vaccine.2005.01.085.
- Background Hansson KE, Rosdahl A, Insulander M, Vene S, Lindquist L, Gredmark-Russ S, Askling HH. Tick-borne Encephalitis Vaccine Failures: A 10-year Retrospective Study Supporting the Rationale for Adding an Extra Priming Dose in Individuals Starting at Age 50 Years. Clin Infect Dis. 2020 Jan 2;70(2):245-251. doi: 10.1093/cid/ciz176.
- Background Lindblom P, Wilhelmsson P, Fryland L, Matussek A, Haglund M, Sjowall J, Vene S, Nyman D, Forsberg P, Lindgren PE. Factors determining immunological response to vaccination against tick-borne encephalitis virus in older individuals. PLoS One. 2014 Jun 26;9(6):e100860. doi: 10.1371/journal.pone.0100860. eCollection 2014.
- Background Stiasny K, Aberle JH, Keller M, Grubeck-Loebenstein B, Heinz FX. Age affects quantity but not quality of antibody responses after vaccination with an inactivated flavivirus vaccine against tick-borne encephalitis. PLoS One. 2012;7(3):e34145. doi: 10.1371/journal.pone.0034145. Epub 2012 Mar 26.
- Background Weinberger B, Keller M, Fischer KH, Stiasny K, Neuner C, Heinz FX, Grubeck-Loebenstein B. Decreased antibody titers and booster responses in tick-borne encephalitis vaccinees aged 50-90 years. Vaccine. 2010 Apr 30;28(20):3511-5. doi: 10.1016/j.vaccine.2010.03.024. Epub 2010 Mar 21.
- Background Askling HH, Rombo L, van Vollenhoven R, Hallen I, Thorner A, Nordin M, Herzog C, Kantele A. Hepatitis A vaccine for immunosuppressed patients with rheumatoid arthritis: a prospective, open-label, multi-centre study. Travel Med Infect Dis. 2014 Mar-Apr;12(2):134-42. doi: 10.1016/j.tmaid.2014.01.005. Epub 2014 Jan 29.
- Background Wagner A, Garner-Spitzer E, Jasinska J, Kollaritsch H, Stiasny K, Kundi M, Wiedermann U. Age-related differences in humoral and cellular immune responses after primary immunisation: indications for stratified vaccination schedules. Sci Rep. 2018 Jun 29;8(1):9825. doi: 10.1038/s41598-018-28111-8.
- Background Hopf S, Garner-Spitzer E, Hofer M, Kundi M, Wiedermann U. Comparable immune responsiveness but increased reactogenicity after subcutaneous versus intramuscular administration of tick borne encephalitis (TBE) vaccine. Vaccine. 2016 Apr 12;34(17):2027-34. doi: 10.1016/j.vaccine.2015.12.057. Epub 2016 Jan 6.
- Background Garner-Spitzer E, Seidl-Friedrich C, Zwazl I, Hofer M, Kinaciyan T, Jarisch R, Stiasny K, Zlabinger GJ, Kundi M, Wiedermann U. Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias. Vaccine. 2018 May 11;36(20):2816-2824. doi: 10.1016/j.vaccine.2018.03.076. Epub 2018 Apr 16.
- Background Garner-Spitzer E, Wagner A, Paulke-Korinek M, Kollaritsch H, Heinz FX, Redlberger-Fritz M, Stiasny K, Fischer GF, Kundi M, Wiedermann U. Tick-borne encephalitis (TBE) and hepatitis B nonresponders feature different immunologic mechanisms in response to TBE and influenza vaccination with involvement of regulatory T and B cells and IL-10. J Immunol. 2013 Sep 1;191(5):2426-36. doi: 10.4049/jimmunol.1300293. Epub 2013 Jul 19.
- Background Svahn A, Linde A, Thorstensson R, Karlen K, Andersson L, Gaines H. Development and evaluation of a flow-cytometric assay of specific cell-mediated immune response in activated whole blood for the detection of cell-mediated immunity against varicella-zoster virus. J Immunol Methods. 2003 Jun 1;277(1-2):17-25. doi: 10.1016/s0022-1759(03)00111-x.
- Background Eliasson H, Olcen P, Sjostedt A, Jurstrand M, Back E, Andersson S. Kinetics of the immune response associated with tularemia: comparison of an enzyme-linked immunosorbent assay, a tube agglutination test, and a novel whole-blood lymphocyte stimulation test. Clin Vaccine Immunol. 2008 Aug;15(8):1238-43. doi: 10.1128/CVI.00434-07. Epub 2008 Jun 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FSME-IMMUN Vaccine | Vaccine | 0.5 ml | Intramuscular |