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Trial record 15 of 36 for:    "Encephalitis, Tick-Borne"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02318069
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
Karolinska Institutet
Helsingfors university
Information provided by (Responsible Party):
Lars Rombo, Sormland County Council, Sweden

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 EUDRA CT 2011 001348-31, unpublished information).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


Condition or disease Intervention/treatment Phase
Tick-borne Encephalitis Biological: FSME-immune Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Humoral Response to TBE Vaccine in Elderly (50+ Year Olds) After Changed Dosage Intervals/Number of Doses?
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Active Comparator: TBE vaccine at 0+30 days
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
0.5 ml im as scheduled in the 5 arms

Active Comparator: TBE vaccine at 0+7+21 days
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
0.5 ml im as scheduled in the 5 arms

Active Comparator: TBE vaccine at 0+30+90 days
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
0.5 ml im as scheduled in the 5 arms

Active Comparator: younger participants
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
0.5 ml im as scheduled in the 5 arms

Active Comparator: double dose of vaccine
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
Biological: FSME-immune
0.5 ml im as scheduled in the 5 arms




Primary Outcome Measures :
  1. Serum concentration of neutralising antibodies against TBE one month after two or three doses. [ Time Frame: 18 months after the first dose ]
    Determination of neutralising antibodies one month after completion of the first years vaccination series


Secondary Outcome Measures :
  1. 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 ]
    Determination of neutralising antibodies one month after the dose which will be given a year later



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318069


Locations
Finland
Dept infectious diseases
Helsingfors, Finland, 00029
Sweden
Dept infectious diseases
Eskilstuna, Sweden, 631 88
Sponsors and Collaborators
Sormland County Council, Sweden
Karolinska Institutet
Helsingfors university
Investigators
Principal Investigator: lars rombo, MD Karolinska Institutet

Responsible Party: Lars Rombo, professor, Sormland County Council, Sweden
ClinicalTrials.gov Identifier: NCT02318069     History of Changes
Other Study ID Numbers: 2011/4-31/2 - B
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs