Primary TBE Vaccination for the Elderly

Region Örebro County

Status and phase: Not yet enrolling; Phase 4

Conditions: Vaccine; Tick-borne Encephalitis

Treatments: Drug: FSME-IMMUN Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04573205

O2019-1

Details and patient eligibility

About

Tick-borne Encephalitis (TBE) can be prevented by vaccine. Vaccine failure, defined as a case of TBE regardless of previous vaccination, has been described and seems to be more predominant with increasing age, suggesting a less effective immune response following with increasing age. In fact previous studies has shown a reduced antibody response in elderly individuals compared to younger when vaccinated against TBE. As a result, in Sweden, an extra vaccine dose has been recommended during the primary vaccine schedule to individuals > 50 years of age. This alternative vaccine schedule has not been tested. The investigator aim to test if an extra vaccine dose in the primary vaccine schedule for those > 50 years of age improves the immune response and offers a corresponding immunity to younger individuals following TBE vaccination.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥ 50 years or between 18-40 years
• Man or woman
• God health
• Written informed consent

Exclusion criteria

• Previous vaccination against TBE
• Previous TBE infection
• Allergy or hypersensitivity to any substance in the vaccine
• Previously known or suspected infection with Japanese encephalitis, Dengue virus, West Nile fever or Yellow fever
• Information on previous vaccination against Yellow fever or Japanese encephalitis
• Acute illness, eg fever with malaise
• Immunosuppression, due to medication or disease
• Previous treatment with Rituximab or equivalent
• Autoimmune disease, including diabetes (diet or tablet-treated diabetes with good metabolic control is accepted, HbA1c < 6 %)
• Obesity, BMI > 40
• Moderate to severe renal failure including hemodialysis, estimated GFR < 30.
• Blood transfusion or immunoglobulins <3 months ago
• Pregnancy
• Any other illness where the investigator consider the subject unsuitable for the study
• The study subject does not want to participate

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

> 50 years

Experimental group

Description:

Healthy individuals \> 50 years of age divided into age groups 50-59 years, 60-69 years and \>70 years, approximately 20 participants in each group. Vaccinated with 4 doses FSME immune Adult intramuscular injection according to the recommended primary vaccine Schedule in Sweden for individuals \> 50 years of age, at time 0, 1, 2 and 7 months.

Treatment:

Drug: FSME-IMMUN Vaccine

< 40 years

Active Comparator group

Description:

Healthy individuals \< 40 years of age. Vaccinated with 3 doses FSME immune Adult intramuscular injection according to the standard recommended primary vaccine at time 0, 1, and 7 months.

Treatment:

Drug: FSME-IMMUN Vaccine