Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

Tick-borne Encephalitis Clinical Trial

Official title:

Humoral Response to TBE Vaccine in Elderly (50+ Year Olds) After Changed Dosage Intervals/Number of Doses?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361776
• Other study ID #: 2011/4-31/2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 25, 2011
• Last updated: November 17, 2015
• Start date: September 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: Sormland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne
• Tick-borne Encephalitis

Intervention

Biological:
• FSME-immune
0.5 ml im as scheduled in the 4 arms

Locations

Country	Name	City	State
Finland	Dept infectious diseases	Helsingfors
Sweden	Dept infectious diseases	Eskilstuna
Sweden	Dept infectious diseases	Karlstad
Sweden	Department of infectious diseases	Örebro
Sweden	Department of infectious diseases	Stockholm
Sweden	Dept infectious diseases	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Sormland County Council, Sweden

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum concentration of neutralising antibodies against TBE one month after the dose which will be given a year later	Determination of neutralising antibodies one month after the dose which will be given a year later	18 months after the first dose has been given	No