Primary TBE Vaccination for the Elderly

November 17, 2023 updated by: Anja Rosdahl, Region Örebro County
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Örebro, Sweden, 70185
        • Region Örebro Län

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serological response to vaccination with TBE vaccine following primary vaccination
Time Frame: 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.
NT measured 1 months after vaccination
Serological response to vaccination with TBE vaccine following the full vaccine scehdule
Time Frame: 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).
NT measured 1 months after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular immunity in young and elderly ( immune cell expression)
Time Frame: Measured 7 days after vaccination
T and B cell populations (flow cytometry) 7 days after TBE vaccination
Measured 7 days after vaccination
Cellular immunity in young and elderly ( cytokine production)
Time Frame: Measured 7 days after vaccination
Cytokine production ( Luminex) 7 days after TBE vaccination
Measured 7 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O2019-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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