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

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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?

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 EUDRA CT 2011 001348-31, unpublished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.
    

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

250

Start Date

January 2015

Completion Date

June 2017

Primary Completion Date

February 2016

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
      

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

NCT02318069

Organization ID

2011/4-31/2 - B


Responsible Party

Principal Investigator

Study Sponsor

Sormland County Council, Sweden

Collaborators

 Karolinska Institutet

Study Sponsor

lars rombo, MD, Principal Investigator, Karolinska Institutet


Verification Date

February 2021