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

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ClinicalTrials.gov Identifier: NCT01398540
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Univ. Prof. Dr. Ursula Wiedermann, 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 60 years of age and 18-40 years old subjects.

Condition or disease Intervention/treatment Phase
Humoral and Cellular Immune Responses Biological: IXIARO Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination [ Time Frame: 7 days after the 2 JE vaccinations ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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

Responsible Party: Univ. Prof. Dr. Ursula Wiedermann, Univ.Prof. MD, PhD, 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: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Encephalitis
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs