6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

Study Description

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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.

Study Design

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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

Arms and Interventions

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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

Austria
Institute for Specific Prophylaxis and Tropical Medicine
Vienna, Kinderspitalgasse 15, Austria, 1090

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( EudraCT Number )
First Posted:	January 17, 2014
Last Update Posted:	February 23, 2015
Last Verified:	February 2015

Additional relevant MeSH terms:

Encephalitis; 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; Leukoencephalopathies; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Antibodies; Immunologic Factors; Physiological Effects of Drugs