6-year Antibody Check After Third Vaccination Against Japanese Encephalitis
This study has been completed.
Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Herwig Kollaritsch, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02039440
First received: January 16, 2014
Last updated: February 20, 2015
Last verified: February 2015
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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 ]
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039440
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
| 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 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 |
ClinicalTrials.gov processed this record on September 23, 2016