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New Study - 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 (Control group 18 years)
  • 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

TBE vaccine at 0+30 days

TBE vaccine at 0+7+21 days

TBE vaccine at 0+30+90 days

younger participants

double dose of vaccine

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

This group of 50 participants will be given two doses of TBE vaccine 0.5 ml FSME immune at the first day of the study and an additional dose at day 30 as well as 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
December 12, 2014
Last Updated
February 9, 2021
Sponsor
Sormland County Council, Sweden
Collaborators
Karolinska Institutet, Helsingfors university
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1. Study Identification

Unique Protocol Identification Number
NCT02318069
Brief Title
New Study - 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
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sormland County Council, Sweden
Collaborators
Karolinska Institutet, Helsingfors university

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The risk for tick borne encephalitis 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. Preliminary results from a previous study showed a higher percentage protected (=titer at least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished information). In the same study, there were no differences between those who were vaccinated 0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences between 2 and 3 doses also in the younger control group. The investigators therefore aim to confirm results in a new study and to add a group with a double dose at day 0 and then a single dose at day 30 and 360
Detailed Description
The risk for tick borne encephalitis 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. The manufacturer of Encepur recommended a total of three doses to this age group using the same regimen as with "accelerated vaccination schedule (0+7+21 days). Unfortunately, geometrical mean of titers after 3 doses with the accelerated schedule is not superior to 2 doses given at 0+30 days The manufacturer of FSME-immune instead recommended 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+90 days). Preliminary results from a previous study showed a higher percentage protected (=titer at least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished information). In the same study, there were no differences between those who were vaccinated 0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences between 2 and 3 doses also in the younger control group Primary aim: To study whether any differences remain before and one month after an additional dose at the following season Secondary aim: To study whether an additional dose of TBE vaccine 2 months after the second dose will improve protection in an age group 50+. Primary endpoint: Serum concentration of neutralising antibodies against tick borne encephalitis one month after an additional dose the following year Secondary endpoints: Serum concentration of neutralising antibodies against tick borne encephalitis one month after two or three doses. Calculation of power: Depend on whether the aim is to determine differences in geometric mean titers or differences in seroconversion rate. The investigators prefer the former but have not settled for the least difference which would be interesting. Inclusion critera: Age 50 years or more. Exclusion critera: previous tick borne encephalitis infection. Previously immunized with tick borne encephalitis vaccine. Anaphylactic reac tion to egg protein. Any disease or therapy which might suppress the immune response. Vaccination should be delayed if a participant has fever. Study design. The investigators intend to give FSME-immune to 4 groups with varying vaccination schedules (see below) 50 participants will be randomized to each Group. 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) Days 0 7 21 30 90 360 Vaccine group 1 x x x Vaccine group 2 x x x x Vaccine group 3 x x x x Vaccine group 4 xx x x Controls x x x Blood samples (10 ml of blood) will be obtained for humoral response as shown below Days 0 60 120 360 400 Group 1 x x x x x Group 2 x x x x x Group 3 x x x x x Group 4 x x x x x Controls x x x x x Analyses Samples are 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
250 (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 vaccine 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
Arm Title
double dose of vaccine
Arm Type
Active Comparator
Arm Description
This group of 50 participants will be given two doses of TBE vaccine 0.5 ml FSME immune at the first day of the study and an additional dose at day 30 as well as one year later
Intervention Type
Biological
Intervention Name(s)
FSME-immune
Intervention Description
0.5 ml im as scheduled in the 5 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 (Control group 18 years) 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
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Dept infectious diseases
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden

12. IPD Sharing Statement

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New Study - Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

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