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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01398540
First received: July 19, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cellular Immunity in the Elderly (Above 65y) After Primary Vaccination Against JE
Biological: IXIARO
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • cellular immunity (cytokine production upon stimulation with Japanese Encephalitis Virus Antigen) 7 days after the 2. JE-vaccination [ Time Frame: 7 days after the 2 JE vaccinations ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: IXIARO
    2 immunizations (0,5ml) with a 28 day interval
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults (≥65 years),
  • both sexes,
  • willingness to sign written informed consent form

Exclusion Criteria:

  • age below 65 years
  • status post japanese 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398540

Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ursula Wiedermann, MD, PhD Institute of Specific Prophylaxis and Tropical medicine, Vienna
  More Information

No publications provided

Responsible Party: Prof. Dr. Ursula Wiedermann-Schmidt, : Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01398540     History of Changes
Other Study ID Numbers: IX-sensesc 1.2
Study First Received: July 19, 2011
Last Updated: July 19, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 26, 2014