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Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

Primary Purpose

Tick-borne Encephalitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FSME-immune
Sponsored by
Sormland County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tick-borne Encephalitis focused on measuring immune response, TBE-vaccine, elderly, additional doses

Eligibility Criteria

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

Inclusion Criteria:

  • Age 50 years or more
  • generally healthy
  • no immunosuppressive condition
  • fertile women must use contraceptives

Exclusion Criteria:

  • Previous TBE infection
  • Previously immunized with TBE vaccine
  • Anaphylactic reaction to egg protein
  • Any disease or therapy which might suppress the immune response
  • Vaccination should be delayed if a participant has fever

Sites / Locations

  • Dept infectious diseases
  • Dept infectious diseases
  • Dept infectious diseases
  • Department of infectious diseases
  • Dept infectious diseases
  • Department of infectious diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

TBE vaccine at 0+30 days

TBE vaccine at 0+7+21 days

TBE vaccinte at 0+30+90 days

younger participants

Arm Description

This group of 50 participants will follow the standard recommendation and will be given TBE vaccine 0.5 ml FSME immune at 0 + 30 days during the first year and an additional dose one year later

This group of 50 participants will will be given TBE vaccine 0.5 ml FSME immune at 0 + 7 +21 days during the first year and an additional dose one year later

This group of 50 participants will will be given TBE vaccine 0.5 ml FSME immune at 0 + 30 + 90 days during the first year and an additional dose one year later

This group of 50 participants in the age group 18-49 years will be given TBE vaccine 0.5 ml FSME immune at 0 +30 days during the first year and an additional dose one year later

Outcomes

Primary Outcome Measures

Serum concentration of neutralising antibodies against TBE one month after two or three doses.
Determination of neutralising antibodies one month after completion of the first years vaccination series

Secondary Outcome Measures

Serum concentration of neutralising antibodies against TBE one month after the dose which will be given a year later
Determination of neutralising antibodies one month after the dose which will be given a year later

Full Information

First Posted
May 25, 2011
Last Updated
November 17, 2015
Sponsor
Sormland County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01361776
Brief Title
Humoral Response to Tick-borne Encephalitis Vaccine in Elderly
Official Title
Humoral Response to TBE Vaccine in Elderly (50+ Year Olds) After Changed Dosage Intervals/Number of Doses?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sormland County Council, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Antibody titers after tick-borne encephalitis (TBE) vaccination are less in elderly and vaccination breakthroughs are more common in this age group. This has prompted Swedish authorities to recommend an additional dose in the initial vaccination schedule (= 0+30+90 days instead of the usually recommended 0+30 days. The investigators intend to evaluate this regime.
Detailed Description
The risk for TBE increases in Sweden. Together with an increased awareness of the possibility to acquire protection by vaccination, this has led to an increase in the number of doses of the vaccine distributed in Sweden each year -now being approximately 400.000. The first year, two doses with an interval of 1 month is recommended for the general population, followed by a third dose approximately one year later and an additional booster dose three years after the third. Recent studies show that the antibody titers against TBE are substantially less in an older population. This is in line with the present recommendation from Austria that booster intervals should be shortened to 3 years in the age group 60+. It is also in line with a report of vaccination failures where 13/27 patients were older than 60 years According to a study by Jilkowa et al, 18 % (38/185) in the age group 60+ did not achieve putative levels of antibody titers after the first two doses. Therefore, the manufacturer of Encepur recommends a total of three doses to this age group using the same regimen as with "accelerated vaccination schedule (0+7+21 days). Unfortunately, GMT (geometrical mean of titers) after 3 doses with the accelerated schedule are not superior to 2 doses given at 0+30 days. The manufacturer of FSME-immun instead recommends that serology should be checked one month after the second dose and that a third dose should be given if titers are not sufficient (0+30+60 days). Unfortunately, determinations of titers in a large number of samples put severe strain on logistics and is not feasible in Sweden. In order to try to improve immunity in the age group 60+ , the Department of Communicable Disease Control and Prevention in Stockholm therefore recommends a third dose two months after the first two doses to the age group 60+ (0+30+60 days). Study design. The investigators intend to give FSME-immune to 3 groups with varying vaccination schedules ( 0+7+21, 0+30 or 0+30+90. 50 participants will be randomized to each group. Half of them will be between 50-59 years and half will be at least 60 years old. A younger age group (50 participants between 18-49 years) will serve as controls and will be given FSME-immune according to standard recommendations (0+30 days). Serum samples (10 ml of blood) will be obtained at five times: 0,60,120,360 and 400 days after first dose Samples will be analysed for neutralising antibodies at the Swedish institute for Infectious disease control - other options possible.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick-borne Encephalitis
Keywords
immune response, TBE-vaccine, elderly, additional doses

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TBE vaccine at 0+30 days
Arm Type
Active Comparator
Arm Description
This group of 50 participants will follow the standard recommendation and will be given TBE vaccine 0.5 ml FSME immune at 0 + 30 days during the first year and an additional dose one year later
Arm Title
TBE vaccine at 0+7+21 days
Arm Type
Active Comparator
Arm Description
This group of 50 participants will will be given TBE vaccine 0.5 ml FSME immune at 0 + 7 +21 days during the first year and an additional dose one year later
Arm Title
TBE vaccinte at 0+30+90 days
Arm Type
Active Comparator
Arm Description
This group of 50 participants will will be given TBE vaccine 0.5 ml FSME immune at 0 + 30 + 90 days during the first year and an additional dose one year later
Arm Title
younger participants
Arm Type
Active Comparator
Arm Description
This group of 50 participants in the age group 18-49 years will be given TBE vaccine 0.5 ml FSME immune at 0 +30 days during the first year and an additional dose one year later
Intervention Type
Biological
Intervention Name(s)
FSME-immune
Intervention Description
0.5 ml im as scheduled in the 4 arms
Primary Outcome Measure Information:
Title
Serum concentration of neutralising antibodies against TBE one month after two or three doses.
Description
Determination of neutralising antibodies one month after completion of the first years vaccination series
Time Frame
18 months after the first dose
Secondary Outcome Measure Information:
Title
Serum concentration of neutralising antibodies against TBE one month after the dose which will be given a year later
Description
Determination of neutralising antibodies one month after the dose which will be given a year later
Time Frame
18 months after the first dose has been given

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 50 years or more generally healthy no immunosuppressive condition fertile women must use contraceptives Exclusion Criteria: Previous TBE infection Previously immunized with TBE vaccine Anaphylactic reaction to egg protein Any disease or therapy which might suppress the immune response Vaccination should be delayed if a participant has fever
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lars rombo, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept infectious diseases
City
Helsingfors
ZIP/Postal Code
00029
Country
Finland
Facility Name
Dept infectious diseases
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Dept infectious diseases
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Department of infectious diseases
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Dept infectious diseases
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Department of infectious diseases
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35101266
Citation
Kantele A, Rombo L, Vene S, Kundi M, Lindquist L, Erra EO. Three-dose versus four-dose primary schedules for tick-borne encephalitis (TBE) vaccine FSME-immun for those aged 50 years or older: A single-centre, open-label, randomized controlled trial. Vaccine. 2022 Feb 23;40(9):1299-1305. doi: 10.1016/j.vaccine.2022.01.022. Epub 2022 Jan 31.
Results Reference
derived

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Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

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