Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Sormland County Council, Sweden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sormland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01361776
First received: May 25, 2011
Last updated: August 27, 2013
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Tick-borne Encephalitis
Biological: FSME-immune
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Humoral Response to TBE Vaccine in Elderly (50+ Year Olds) After Changed Dosage Intervals/Number of Doses?

Resource links provided by NLM:


Further study details as provided by Sormland County Council, Sweden:

Primary Outcome Measures:
  • Serum concentration of neutralising antibodies against TBE one month after two or three doses. [ Time Frame: 18 months after the first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months after the first dose has been given ] [ Designated as safety issue: No ]
    Determination of neutralising antibodies one month after the dose which will be given a year later


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TBE vaccine at 0+30 days
This group of 50 participants will follow the standard recommendation and will be given TBE vaccine at 0 + 30 days during the first year and an additional dose one year later
Biological: FSME-immune
0.5 ml im as scheduled in the 4 arms
Active Comparator: TBE vaccine at 0+7+21 days
This group of 50 participants will will be given TBE vaccine at 0 + 7 +21 days during the first year and an additional dose one year later
Biological: FSME-immune
0.5 ml im as scheduled in the 4 arms
Active Comparator: TBE vaccinte at 0+30+90 days
This group of 50 participants will will be given TBE vaccine at 0 + 30 + 90 days during the first year and an additional dose one year later
Biological: FSME-immune
0.5 ml im as scheduled in the 4 arms
Active Comparator: younger participants
This group of 50 participants in the age group 18-49 years will be given TBE vaccine at 0 +30 days during the first year and an additional dose one year later
Biological: FSME-immune
0.5 ml im as scheduled in the 4 arms

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361776

Locations
Finland
Dept infectious diseases Not yet recruiting
Helsingfors, Finland, 00029
Contact: Anu Kantele, Assoc. Prof       anu.kantele@hus.fi   
Principal Investigator: Anu Kantele, Assoc Prof         
Sweden
Dept infectious diseases Recruiting
Eskilstuna, Sweden, 631 88
Contact: lars rombo, MD    +4616103551    lars.rombo@dll.se   
Principal Investigator: lars rombo, MD         
Dept infectious diseases Not yet recruiting
Karlstad, Sweden, 651 85
Contact: Ingemar Hallén, MD       Ingemar.hallen@liv.se   
Principal Investigator: Ingemar Hallén, MD         
Department of infectious diseases Recruiting
Stockholm, Sweden, 17176
Contact: Helena Hervius, MD PhD       helena.hervius-askling@karolinska.se   
Principal Investigator: Helena Hervius-Askling, MD PhD         
Dept infectious diseases Not yet recruiting
Uppsala, Sweden, 751 85
Contact: Karlis Pauksens, Assoc Prof       karlis.pauksens@akademiska.se]   
Principal Investigator: Karlis Pauksens, MD, PhD         
Department of infectious diseases Not yet recruiting
Örebro, Sweden
Contact: Torbjörn Noren, MD PhD       torbjorn.noren@orebroll.se   
Principal Investigator: Torbjörn Norén, MD PhD         
Sponsors and Collaborators
Sormland County Council, Sweden
Investigators
Principal Investigator: lars rombo, MD Karolinska Institutet
  More Information

No publications provided

Responsible Party: lars rombo, sormland county council
ClinicalTrials.gov Identifier: NCT01361776     History of Changes
Other Study ID Numbers: 2011/4-31/2
Study First Received: May 25, 2011
Last Updated: August 27, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sormland County Council, Sweden:
immune response
TBE-vaccine
elderly
additional doses

Additional relevant MeSH terms:
Tick-Borne Diseases
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 23, 2014