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Primary TBE Vaccination for the Elderly

Primary Purpose

Tick-borne Encephalitis, Vaccine

Status

Not yet recruiting

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

FSME-IMMUN Vaccine

About this trial

This is an interventional prevention trial for Tick-borne Encephalitis focused on measuring Elderly, Tick-borne Encephalitis, Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Region Örebro Län

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

> 50 years

< 40 years

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

Cellular immunity in young and elderly ( immune cell expression)

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

Cellular immunity in young and elderly ( cytokine production)

Cytokine production ( Luminex) 7 days after TBE vaccination

Full Information

NCT ID

NCT04573205

First Posted

September 21, 2020

Last Updated

April 26, 2022

Sponsor

Region Örebro County

1. Study Identification

Unique Protocol Identification Number

NCT04573205

Brief Title

Primary TBE Vaccination for the Elderly

Official Title

Primary TBE Vaccination for the Elderly

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Örebro County

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tick-borne Encephalitis, Vaccine

Keywords

Elderly, Tick-borne Encephalitis, Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

> 50 years

Arm Type

Experimental

Arm Description

Arm Title

< 40 years

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

FSME-IMMUN Vaccine

Intervention Description

0.5 ml intramuscular injection scheduled in the two different arms

Primary Outcome Measure Information:

Title

Serological response to vaccination with TBE vaccine following primary vaccination

Description

Time Frame

NT measured 1 months after vaccination

Title

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

Description

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).

Time Frame

NT measured 1 months after vaccination

Secondary Outcome Measure Information:

Title

Cellular immunity in young and elderly ( immune cell expression)

Description

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

Time Frame

Measured 7 days after vaccination

Title

Cellular immunity in young and elderly ( cytokine production)

Description

Cytokine production ( Luminex) 7 days after TBE vaccination

Time Frame

Measured 7 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anja Rosdahl

Phone

+46196021157

anja.rosdahl@regionorebrolan.se

Facility Information:

Facility Name

Region Örebro Län

City

Örebro

ZIP/Postal Code

70185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

18514730

Citation

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

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

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Citation

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PubMed Identifier

30843030

Citation

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Citation

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Primary TBE Vaccination for the Elderly

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