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6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

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. Identifier: NCT02039440
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : February 23, 2015
Information provided by (Responsible Party):
Herwig Kollaritsch, Medical University of Vienna

Brief Summary:
The purpose of this study is to determine whether there are persisting antibodies against Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or confirm mathematical models accordingly.

Condition or disease Intervention/treatment Phase
Post Other Specified Vaccination Encephalitis Other: Blood draw Phase 4

Detailed Description:

Japanese Encephalitis (JE) is a potentially devastating mosquito-borne viral disease. The JE virus (JEV), a Flavivirus, is endemic to many regions in Asia, and while JE is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to Asia are usually naïve to the virus and may be at risk for contracting JE at any age.

The present study aims to investigate antibody titers at approximately 6 years after the third dose of JE vaccine (JE-VC), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Single arm
1 blood draw
Other: Blood draw
One-time blood draw

Primary Outcome Measures :
  1. Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT [ Time Frame: 1.5 years ]

Other Outcome Measures:
  1. Projected mean duration of protection after a booster dose of JE-VC [ Time Frame: 1.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects who received a booster dose of JE-VC in study IC51-311
  • Subjects who are willing to give written informed consent to participate in the trial

Exclusion Criteria:

  • Subjects who received a further dose of any Japanese Encephalitis Vaccine since study IC51-311
  • Severe immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy
  • simultaneous participation in another clinical study

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 identifier (NCT number): NCT02039440

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Institute for Specific Prophylaxis and Tropical Medicine
Vienna, Kinderspitalgasse 15, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Herwig Kollaritsch, Prof. Dr. Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin 1090 Wien, Kinderspitalgasse 15

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Responsible Party: Herwig Kollaritsch, Ao.Univ.-Prof., Medical University of Vienna Identifier: NCT02039440     History of Changes
Other Study ID Numbers: 311_FU2013
2013-004366-34 ( EudraCT Number )
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalomyelitis, Acute Disseminated
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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs