6-year Antibody Check After Third Vaccination Against Japanese Encephalitis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02039440 |
Recruitment Status
:
Completed
First Posted
: January 17, 2014
Last Update Posted
: February 23, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post Other Specified Vaccination Encephalitis | Other: Blood draw | Phase 4 |
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 : | 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 |

Arm | Intervention/treatment |
---|---|
Single arm
1 blood draw
|
Other: Blood draw
One-time blood draw
|
- Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT [ Time Frame: 1.5 years ]
- Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT [ Time Frame: 1.5 years ]
- Projected mean duration of protection after a booster dose of JE-VC [ Time Frame: 1.5 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039440
Austria | |
Institute for Specific Prophylaxis and Tropical Medicine | |
Vienna, Kinderspitalgasse 15, Austria, 1090 |
Principal Investigator: | Herwig Kollaritsch, Prof. Dr. | Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin 1090 Wien, Kinderspitalgasse 15 |
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 Key Record Dates |
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 |