Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Humoral and Cellular Immune Responses

Treatments: Biological: IXIARO

Study type: Interventional

Funder types: Other

Identifiers

NCT01398540

IX-sensesc 1.2

Details and patient eligibility

About

The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adults (18-40 years old)
• adults (≥60 years),
• both sexes
• willingness to sign written informed consent form

Exclusion criteria

• age below 18 years or between 41-59 years old
• status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection
• previous immunization against yellow fever, japanese encephalitis (dengue or WNV)
• current acute infection (body temperature above 37,9°C)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

elderly

Experimental group

Description:

subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO

Treatment:

Biological: IXIARO

young

Experimental group

Description:

subjects 18 to 40 years old, receiving 2 immunisations with IXIARO

Treatment:

Biological: IXIARO