6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

This study has been completed.
Information provided by (Responsible Party):
Herwig Kollaritsch, Medical University of Vienna
ClinicalTrials.gov Identifier:
First received: January 16, 2014
Last updated: February 20, 2015
Last verified: February 2015

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 Intervention Phase
Post Other Specified Vaccination Encephalitis
Other: Blood draw
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Projected mean duration of protection after a booster dose of JE-VC [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: February 2014
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm
1 blood draw
Other: Blood draw
One-time blood draw

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02039440

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

No publications provided

Responsible Party: Herwig Kollaritsch, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02039440     History of Changes
Other Study ID Numbers: 311_FU2013, 2013-004366-34
Study First Received: January 16, 2014
Last Updated: February 20, 2015
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalomyelitis, Acute Disseminated
Arbovirus Infections
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Immune System Diseases
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 13, 2015