Clinical trial NCT01386827: Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis
Official title: Ability of the New Vero-cell-derived Inactivated Japanese Encephalitis Vaccine (IXIARO) to Elicit a Booster Response in Travellers Previously Vaccinated With Traditional Mouse-brain Derived Vaccine (JE-MB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Keywords: Ixiaro
japanese encephalitis vaccine
booster
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2011-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Antibody titers 1 month after last vaccine dose
timeFrame: 1 month
Secondary outcomes:
measure: Antibody titers two years after vaccination
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Haartman Institute, University of Helsinki
name: Elina Erra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of infectious diseases Stockholm, Sweden
name: Lars Lindqvist, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haartman Institute, University of Helsinki
name: Eili Huhtamo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haartman Institute, University of Helsinki
name: Olli Vapalahti, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haartman Institute, University of Helsinki
name: Sari Pakkanen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Institute of Infectious Disease Control
name: Sirkka Vene, BMA
role: PRINCIPAL_INVESTIGATOR
affiliation: Travel clinic, Postitalo, Lääkärikeskus
name: Jukka Riutta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Anu Kantele, MD PhD
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Lars Rombo, MD PhD
role: STUDY_DIRECTOR
References:
citation: Erra EO, Askling HH, Rombo L, Riutta J, Vene S, Yoksan S, Lindquist L, Pakkanen SH, Huhtamo E, Vapalahti O, Kantele A. A single dose of vero cell-derived Japanese encephalitis (JE) vaccine (Ixiaro) effectively boosts immunity in travelers primed with mouse brain-derived JE vaccines. Clin Infect Dis. 2012 Sep;55(6):825-34. doi: 10.1093/cid/cis542. Epub 2012 Jun 13.