Trial record 3 of 3 for:    Acute Disseminated Encephalomyelitis

6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Herwig Kollaritsch, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02039440
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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 ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT02039440

Locations
Austria
Institute for Specific Prophylaxis and Tropical Medicine Not yet recruiting
Vienna, Kinderspitalgasse 15, Austria, 1090
Contact: Ines Zwazl    004314016038276    tropenmedizin@gmail.com   
Principal Investigator: Herwig Kollaritsch, Prof. Dr.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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: January 16, 2014
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission

Additional relevant MeSH terms:
Encephalomyelitis, Acute Disseminated
Encephalitis
Encephalitis, Japanese
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
Leukoencephalopathies
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014