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

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01386827

382/E7/07

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

A) primary immunization with MB-JEV

Active Comparator group

Description:

Volunteers immunized with MB-JEV

Treatment:

Biological: Mouse brain derived japanese encephalitis vaccine (MB-JEV)

Primary and booster MBJEV vaccinations

Active Comparator group

Description:

Booster immunization with MB-JEV of vaccinees primed with MB-JEV

Treatment:

Biological: Primary and booster immunizations with MB-JEV

C) primary immunizations with Ixiaro

Active Comparator group

Description:

Primary immunization with Ixiaro 2 dose

Treatment:

Biological: C) primary immunizations with Ixiaro

S) Ixiaro booster to MBJEV primed

Active Comparator group

Description:

Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV

Treatment:

Biological: S) Ixiaro booster to MBJEV primed