NCT03971058

Brief Summary

The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

May 29, 2019

Last Update Submit

May 29, 2019

Conditions

Japanese Encephalitis Vaccine

Keywords

Japanese Encephalitis vaccineimmune responses

Outcome Measures

Primary Outcomes (1)

  • JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3

    Testing the difference of the JEV antibodies increase between young and elderly adults between Visit 1 (before booster vaccination) and Visit 3 (day 42+/-4 after Booster vaccination)

    Visit 3 day 42+/-4

Secondary Outcomes (6)

  • Testing the difference of the JEV antibody titer between young and elderly adults

    Visit 1, day 0) till Visit 4 (day 168 +/- 14)

  • Testing cellular immunity

    Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2).

  • Testing of lymphocyte populations with FACS analysis

    Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2) and 42 days (Visit 3, day 42 (+/-4) after booster vaccination

  • Testing of CMV serology

    Visit 1, day 0

  • TBE titer increase/course

    Visit 1, day 0), seven days (Visit 2, day 7 (+2), 42 days (Visit 3, day 42 (+/-4) und 6 Months (Visit 4, day 168 (+/- 14)

  • +1 more secondary outcomes

Study Arms (2)

young individuals

ACTIVE COMPARATOR

Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Biological: IXIARO®- Japanese Encephalitis vaccine

elderly individuals

ACTIVE COMPARATOR

Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Biological: IXIARO®- Japanese Encephalitis vaccine

Interventions

IXIARO®- Japanese Encephalitis vaccineBIOLOGICAL

Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

elderly individualsyoung individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participation in the preceeding study "IXIARO®-senescence" (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of 60.
  • good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM)
  • willingness to sign written informed consent

You may not qualify if:

  • Already received an booster (3rd dose) of IXIARO ®
  • Vaccination with other JE vaccine (e.g. Je-vax)
  • past infection with the JEV
  • immunosuppressive therapy (intake\>14d) within 30 days before IXIARO booster till V3 (day 42+/-4), Corticosteroids like Prednisolon \> and = 20mg/day; allowed: topic or inhalative application
  • immunodeficiency or st. p. organ transplantation
  • autoimmune disease except vitiligo or diseases of the thyroid gland with thyroid hormon substitution therapy
  • immuntherapy within 2 weeks before or after Ixiaro Booster
  • current acute infection or exacerbation of a chronic illness
  • cancer within the last 5 years
  • clinically significant haematological, renal, pulmonary, hepatic, neurological, cardiovascular disease which is not treated adequately within 12 weeks before Ixiaro booster
  • known infection with HIV, Hep B and Hep C
  • Guillain - Barré- Syndrome (GBS) - anamnestic
  • anamnestic anaphylaxie, atopy oder severe hypersensivity against ingredients of IXIARO
  • drug abuse/alcohol abuse
  • pregnancy and breastfeeding
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

RECRUITING

Study Officials

  • Ursula Wiedermann-Schmidt, Univ Prof MD

    Medical University of Vienna, ISPTM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Studien Team

CONTACT

+43140160isptm-studien@meduniwien.ac.at

Ines Zwazl, BA

CONTACT

+43140160ines.zwazl@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. MD PhD

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 3, 2019

Study Start

March 1, 2019

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

June 3, 2019

Record last verified: 2019-05

Locations

AU(2)