We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01398540
Recruitment Status : Unknown
Verified June 2010 by Medical University of Vienna.
Recruitment status was:  Enrolling by invitation
First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Information provided by:
Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment Phase
Cellular Immunity in the Elderly (Above 65y) After Primary Vaccination Against JE Biological: IXIARO Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Intervention Details:
    Biological: IXIARO
    2 immunizations (0,5ml) with a 28 day interval

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398540

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

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
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs