6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Post Other Specified Vaccination Encephalitis

Treatments: Other: Blood draw

Study type: Interventional

Funder types: Other

Identifiers

NCT02039440

311_FU2013

2013-004366-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

67 participants in 1 patient group

Single arm

Other group

Description:

1 blood draw

Treatment:

Other: Blood draw