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Primary TBE Vaccination for the Elderly

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ClinicalTrials.gov Identifier: NCT04573205
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Anja Rosdahl, Region Örebro County

Study Description
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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
Tick-borne Encephalitis Vaccine Drug: FSME-IMMUN Vaccine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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

  2. Cellular immunity in young and elderly ( cytokine production) [ Time Frame: Measured 7 days after vaccination ]
    Cytokine production ( Luminex) 7 days after TBE vaccination


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573205


Contacts
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Contact: Anja Rosdahl +46196021157 anja.rosdahl@regionorebrolan.se

Locations
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Sweden
Region Örebro Län
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
More Information
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Publications:

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Responsible Party: Anja Rosdahl, Principal Investigator, Region Örebro County
ClinicalTrials.gov Identifier: NCT04573205    
Other Study ID Numbers: O2019-1
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Region Örebro County:
Elderly
Tick-borne Encephalitis
Vaccine
Additional relevant MeSH terms:
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Encephalitis, Tick-Borne
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Tick-Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections