6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

Post Other Specified Vaccination Encephalitis Clinical Trial

Official title:

Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039440
• Other study ID #: 311_FU2013
• Secondary ID: 2013-004366-34
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2014
• Last updated: February 20, 2015
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Post Other Specified Vaccination Encephalitis

Intervention

Other:
• Blood draw
One-time blood draw

Locations

Country	Name	City	State
Austria	Institute for Specific Prophylaxis and Tropical Medicine	Vienna	Kinderspitalgasse 15

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Projected mean duration of protection after a booster dose of JE-VC		1.5 years	No
Primary	Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT		1.5 years	No
Secondary	Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers =1:10 in a PRNT		1.5 years	No