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AzTrials

Tick-borne EncephalitisPhase 4NCT04573205

Primary TBE Vaccination for the Elderly

A Phase 4 study testing FSME-IMMUN Vaccine in people with Tick-borne Encephalitis and Vaccine, run by Region Örebro County at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tick-borne Encephalitis, Vaccine
What is being tested?
FSME-IMMUN Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSweden
Study dates
Jan 2024to Jan 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults ≥ 50 years or between 18-40 years
  • Man or woman
  • God health
  • Written informed consent

Who cannot join

  • Previous vaccination against TBE
  • Previous TBE infection
  • Allergy or hypersensitivity to any substance in the vaccine
  • Previously known or suspected infection with Japanese encephalitis, Dengue virus, West Nile fever or Yellow fever
  • Information on previous vaccination against Yellow fever or Japanese encephalitis
  • Acute illness, eg fever with malaise
Show all 15Show fewer
  • Immunosuppression, due to medication or disease
  • Previous treatment with Rituximab or equivalent
  • Autoimmune disease, including diabetes (diet or tablet-treated diabetes with good metabolic control is accepted, HbA1c < 6 %)
  • Obesity, BMI > 40
  • Moderate to severe renal failure including hemodialysis, estimated GFR < 30.
  • Blood transfusion or immunoglobulins <3 months ago
  • Pregnancy
  • Any other illness where the investigator consider the subject unsuitable for the study
  • The study subject does not want to participate

Trial locations and contacts

1 site in 1 country.

Anja Rosdahl contact

+46196021157

anja.rosdahl@regionorebrolan.se

Sweden1 site

  • Region Örebro Län

    Örebro, 70185

Other trials in Sweden

About this study

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.

Being tested
FSME-IMMUN Vaccine
Keywords
Elderly, Tick-borne Encephalitis, Vaccine
Medical subject headings
Encephalitis, Tick-Borne

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FSME-IMMUN VaccineDrug

    0.5 ml intramuscular injection scheduled in the two different arms

Study groups in NCT04573205
Study groupRoleWhat they receive
> 50 yearsExperimentalHealthy individuals > 50 years of age divided into age groups 50-59 years, 60-69 years and >70 years, approximately 20 participants in each group. Vaccinated with 4 doses FSME immune Adult intramuscular injection according to the recommended primary vaccine Schedule in Sweden for individuals > 50 years of age, at time 0, 1, 2 and 7 months.
Receives: Drug: FSME-IMMUN Vaccine
< 40 yearsActive comparatorHealthy individuals < 40 years of age. Vaccinated with 3 doses FSME immune Adult intramuscular injection according to the standard recommended primary vaccine at time 0, 1, and 7 months.
Receives: Drug: FSME-IMMUN Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serological response to vaccination with TBE vaccine following primary vaccination

    The proportion of individuals > 50 years that achieves protective levels following the extra primary vaccine dose compared to the proportion of individuals tha achieve protective levels of neutralizing antibodies following the second vaccine dose in those < 40 years.

    Measured: NT measured 1 months after vaccination

  2. Serological response to vaccination with TBE vaccine following the full vaccine scehdule

    The proportion of individuals > 50 years that achieves protective levels of neutralizing antibodies following the final primary schedule ( dose 4), compared to those < 40 years ( 3 doses).

    Measured: NT measured 1 months after vaccination

Secondary outcomes (2)

  1. Cellular immunity in young and elderly ( immune cell expression)

    T and B cell populations (flow cytometry) 7 days after TBE vaccination

    Measured: Measured 7 days after vaccination

  2. Cellular immunity in young and elderly ( cytokine production)

    Cytokine production ( Luminex) 7 days after TBE vaccination

    Measured: Measured 7 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study startJan 2024 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04573205
Sponsor's protocol ID
O2019-1
Status last verified
Nov 2023
First submitted
21 Sep 2020
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lindquist L, Vapalahti O. Tick-borne encephalitis. Lancet. 2008 May 31;371(9627):1861-71. doi: 10.1016/S0140-6736(08)60800-4.

    PubMed 18514730

  • 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.

    PubMed 22699436

  • 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.

    PubMed 19527104

  • 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.

    PubMed 15837226

  • 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.

    PubMed 30843030

  • 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.

    PubMed 24967619

  • 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.

    PubMed 22461903

  • 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.

    PubMed 20332047

  • 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.

    PubMed 24529746

  • 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.

    PubMed 29959387

  • 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.

    PubMed 26768126

  • 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.

    PubMed 29673942

  • 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.

    PubMed 23872054

  • 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.

    PubMed 12799036

  • 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.

    PubMed 18562568

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FSME-IMMUN Vaccine in people with Tick-borne Encephalitis and Vaccine, run by Region Örebro County at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anja Rosdahl (+46196021157, anja.rosdahl@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serological response to vaccination with TBE vaccine following primary vaccination (time frame: NT measured 1 months after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04573205, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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