- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02039440
6-year Antibody Check After Third Vaccination Against Japanese Encephalitis
Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kinderspitalgasse 15
-
Vienna, Kinderspitalgasse 15, Austria, 1090
- Institute for Specific Prophylaxis and Tropical Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single arm
1 blood draw
|
One-time blood draw
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT
Time Frame: 1.5 years
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT
Time Frame: 1.5 years
|
1.5 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Projected mean duration of protection after a booster dose of JE-VC
Time Frame: 1.5 years
|
1.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Herwig Kollaritsch, Prof. Dr., Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin 1090 Wien, Kinderspitalgasse 15
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Leukoencephalopathies
- Encephalitis, Japanese
- Encephalitis
- Encephalomyelitis, Acute Disseminated
Other Study ID Numbers
- 311_FU2013
- 2013-004366-34 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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