Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: Mouse brain derived japanese encephalitis vaccine (MB-JEV); Biological: Primary and booster immunizations with MB-JEV; Biological: C) primary immunizations with Ixiaro; Biological: S) Ixiaro booster to MBJEV primed

• Registration Number: NCT01386827
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro.

Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune responses in four groups: A) primary immunization with BMJEV, B) primary and secondary immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of serum samples collected before and after vaccination.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-01
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Male and female travellers ≥ 18 years of age.

  • General good health.
  • Written informed consent.
  • Ability to attend all visits scheduled in this study.
  • Travellers who have previously got a primary vaccination series of 2 or 3 doses of JE-MB and now receive a booster vaccination , either MB-JEV or IXIARO, at the travel clinic for their journey to Asia, OR
  • Travellers with no previous vaccination against JE who are given the primary vaccination series with IXIARO at a travel clinic prior to their journey to Asia.

Exclusion Criteria

• • < 18 years of age.
• Acute disease at the time of enrollment.
• Pregnancy or lactation.
• Known immunodeficiency or immune suppressive treatment.
• Any chronic illness that might interfere with the immune response; history of JE.
• Alcohol or drug abuse.
• Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A) primary immunization with MB-JEV	Mouse brain derived japanese encephalitis vaccine (MB-JEV)	Volunteers immunized with MB-JEV
Primary and booster MBJEV vaccinations	Primary and booster immunizations with MB-JEV	Booster immunization with MB-JEV of vaccinees primed with MB-JEV
C) primary immunizations with Ixiaro	C) primary immunizations with Ixiaro	Primary immunization with Ixiaro 2 dose
S) Ixiaro booster to MBJEV primed	S) Ixiaro booster to MBJEV primed	Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV

Primary Outcome Measures

Name	Time	Method
Antibody titers 1 month after last vaccine dose	1 month	Determination of antibody titers 1 month after last vaccine dose

Secondary Outcome Measures

Name	Time	Method
Antibody titers two years after vaccination	2 years	Measurement of antibody titers two years after vaccination