Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

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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?

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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Serum concentration of neutralising antibodies against TBE one month after two or three doses.

Secondary Outcome

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

Condition

Tick-borne Encephalitis

Intervention

FSME-immune

Study Arms / Comparison Groups

 TBE vaccine at 0+30 days
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

200

Start Date

September 2011

Completion Date

June 2014

Primary Completion Date

December 2013

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

lars rombo, MD, , 

Location Countries

Finland

Location Countries

Finland

Administrative Informations


NCT ID

NCT01361776

Organization ID

2011/4-31/2


Responsible Party

Principal Investigator

Study Sponsor

Sormland County Council, Sweden


Study Sponsor

lars rombo, MD, Principal Investigator, Karolinska Institutet


Verification Date

November 2015