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

NCT02318069 | Completed Phase 2 DMC

• 1 other identifier: 2011/4-31/2 - B
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 2

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 EUDRA CT 2011 001348-31, unpublished information).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

Conditions

Tick-borne Encephalitis

Keywords

immune response; TBE-vaccine; elderly; additional 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 (5)

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 vaccine 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

double dose of vaccine

ACTIVE COMPARATOR

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

Interventions

FSME-immune BIOLOGICAL

0.5 ml im as scheduled in the 5 arms

TBE vaccine at 0+30 days; TBE vaccine at 0+30+90 days; TBE vaccine at 0+7+21 days; double dose of vaccine; younger participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years or more (Control group 18 years)
• 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

Sponsors & Collaborators

• Sormland County Council, Sweden: lead
• Karolinska Institutet: collaborator
• Helsingfors university: collaborator

Study Sites (2)

Dept infectious diseases

Helsinki, 00029, Finland

Location

Dept infectious diseases

Eskilstuna, 631 88, Sweden

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory 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: December 12, 2014
• First Posted: December 17, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2017
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

FI (1); SE (1)