NCT01361776

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

May 25, 2011

Last Update Submit

November 17, 2015

Conditions

Tick-borne Encephalitis

Keywords

immune responseTBE-vaccineelderlyadditional doses

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months after the first dose

Secondary Outcomes (1)

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

    18 months after the first dose has been given

Study Arms (4)

TBE vaccine at 0+30 days

ACTIVE COMPARATOR

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

Biological: FSME-immune

TBE vaccine at 0+7+21 days

ACTIVE COMPARATOR

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

Biological: FSME-immune

TBE vaccinte at 0+30+90 days

ACTIVE COMPARATOR

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

Biological: FSME-immune

younger participants

ACTIVE COMPARATOR

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

Biological: FSME-immune

Interventions

FSME-immuneBIOLOGICAL

0.5 ml im as scheduled in the 4 arms

TBE vaccine at 0+30 daysTBE vaccine at 0+7+21 daysTBE vaccinte at 0+30+90 daysyounger participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dept infectious diseases

Helsingfors, 00029, Finland

Location

Dept infectious diseases

Eskilstuna, 631 88, Sweden

Location

Dept infectious diseases

Karlstad, 651 85, Sweden

Location

Department of infectious diseases

Örebro, Sweden

Location

Department of infectious diseases

Stockholm, 17176, Sweden

Location

Dept infectious diseases

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 35101266DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • lars rombo, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 25, 2011

First Posted

May 27, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

SE(5)FI(1)