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Primary TBE Vaccination for the Elderly

Sponsor
Region Örebro County (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04573205
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: FSME-IMMUN Vaccine
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Primary TBE Vaccination for the Elderly
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: > 50 years

Healthy 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.

Drug: FSME-IMMUN Vaccine
0.5 ml intramuscular injection scheduled in the two different arms
Active Comparator: < 40 years

Healthy 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.

Drug: FSME-IMMUN Vaccine
0.5 ml intramuscular injection scheduled in the two different arms

Outcome Measures

Primary Outcome Measures

  1. Serological response to vaccination with TBE vaccine following primary vaccination [NT measured 1 months after 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.

  2. Serological response to vaccination with TBE vaccine following the full vaccine scehdule [NT measured 1 months after vaccination]

    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).

Secondary Outcome Measures

  1. Cellular immunity in young and elderly ( immune cell expression) [Measured 7 days after vaccination]

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

  2. Cellular immunity in young and elderly ( cytokine production) [Measured 7 days after vaccination]

    Cytokine production ( Luminex) 7 days after TBE vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Adults ≥ 50 years or between 18-40 years

  • Man or woman

  • God health

  • Written informed consent

Exclusion Criteria:

  • 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Region Örebro Län Örebro Sweden 70185

Sponsors and Collaborators

  • Region Örebro County

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anja Rosdahl, Principal Investigator, Region Örebro County
ClinicalTrials.gov Identifier:
NCT04573205
Other Study ID Numbers:
  • O2019-1
First Posted:
Oct 5, 2020
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Anja Rosdahl, Principal Investigator, Region Örebro County
Elderly
Tick-borne Encephalitis
Vaccine
Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis

Study Results

No Results Posted as of Apr 27, 2022