Detailed analysis of the immune responses after vaccination against Japanese Encephalitis in the elderly.

Characterization of cellular and humoral immunity in the elderly upon vaccination with the purified inactivated Japanese Encephalitis Vaccine IXIARO®

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020450-33-AT

Enrollment

Registered

2010-05-28

Start date

2010-06-23

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 65 years of age in comparison to subjects aged between 18 and 40 years. MedDRA version: 14.0 Level: LLT Classification code 10069544 Term: Japanese encephalitis immunization System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: IXIARO(R) Product Name: IXIARO Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adults (18-40 years and =65 years with no upper age limit), both sexes, willingness to sign written informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: age below 18 years, age between 41 and 64 years; prior japanese encephalitis, TBE, dengue, yellow fever or West Nile virus infection, yellow fever vaccination within the last 10 years, TBE vaccination within the last 30 days; vaccination against dengue or West Nile Virus; current acute infection (body temperature above 37,9°C)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Antibody titres 10 weeks after the first vaccination (=6 weeks after the 2. vaccination) ;Timepoint(s) of evaluation of this end point: visit 3: d70(+/-4) 6 weeks after the second vaccination;Main Objective: Antibody titres 10 weeks after the first vaccination (=6 weeks after the 2. vaccination) ;Secondary Objective: Cellular immunity (cytokine production) 7 days after the second japanese encephalitis vaccination. Cellular markers of different lymphocyte subsets.	—

Measure

Time frame

Primary end point(s): Antibody titres 10 weeks after the first vaccination (=6 weeks after the 2. vaccination) ;Timepoint(s) of evaluation of this end point: visit 3: d70(+/-4) 6 weeks after the second vaccination;Main Objective: Antibody titres 10 weeks after the first vaccination (=6 weeks after the 2. vaccination) ;Secondary Objective: Cellular immunity (cytokine production) 7 days after the second japanese encephalitis vaccination. Cellular markers of different lymphocyte subsets.

—

Secondary

Measure	Time frame
Secondary end point(s): cellular immunity (cytokine production upon stimulation with Japanese Encephalitis Virus Antigen) 7 days after the 2. vaccination (visit 2).;Timepoint(s) of evaluation of this end point: visit 2: 7 days after the 2. vaccination ( (d35+2))	—

Countries

Austria

Contacts

Public ContactInstitute of Specific Prophylaxis a

Institute of Specific Prophylaxis and Tropical Medicine

angelika.wagner@meduniwien.ac.at0043140160-38255

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026