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Completed

NCT Number: NCT02039440

6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

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.

Completed

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Key information

Conditions

Post Other Specified Vaccination Encephalitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute for Specific Prophylaxis and Tropical Medicine

Vienna, Kinderspitalgasse 15, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Draw

Other

One-time blood draw

Primary outcomes

  1. Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT

    Time frame: 1.5 years

Secondary outcomes

  1. Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT

    Time frame: 1.5 years

Other outcomes

  1. Projected mean duration of protection after a booster dose of JE-VC

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 17, 2014
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.