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

Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.

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.

Study Overview

• Status: Completed
• Conditions: Humoral and Cellular Immune Responses
• Intervention / Treatment: Biological: IXIARO

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: elderly; subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO	Biological: IXIARO; 2 immunizations (0,5ml) with a 28 day interval
Experimental: young; subjects 18 to 40 years old, receiving 2 immunisations with IXIARO	Biological: IXIARO; 2 immunizations (0,5ml) with a 28 day interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination	7 days after the 2 JE vaccinations

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Ursula Wiedermann, MD, PhD, Institute of Specific Prophylaxis and Tropical medicine, Vienna

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis
• Other Study ID Numbers: IX-sensesc 1.2