Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis
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)
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2008
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 30, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedOctober 28, 2011
October 1, 2011
3.2 years
June 30, 2011
October 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibody titers 1 month after last vaccine dose
Determination of antibody titers 1 month after last vaccine dose
1 month
Secondary Outcomes (1)
Antibody titers two years after vaccination
2 years
Study Arms (4)
A) primary immunization with MB-JEV
ACTIVE COMPARATORVolunteers immunized with MB-JEV
Primary and booster MBJEV vaccinations
ACTIVE COMPARATORBooster immunization with MB-JEV of vaccinees primed with MB-JEV
C) primary immunizations with Ixiaro
ACTIVE COMPARATORPrimary immunization with Ixiaro 2 dose
S) Ixiaro booster to MBJEV primed
ACTIVE COMPARATORActual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV
Interventions
a) 2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 immunization and one booster dose of Ixiaro 0.5 ml \> 2 years later
2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 as primary immunization and one booster dose of 0.5 ml \> 2 years later
2 0.5 ml doses of Ixiaro 28 days apart
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- \< 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Karolinska Institutetcollaborator
Related Publications (1)
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.
PMID: 22696017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elina Erra, MD
Haartman Institute, University of Helsinki
- PRINCIPAL INVESTIGATOR
Lars Lindqvist, MD PhD
Department of infectious diseases Stockholm, Sweden
- PRINCIPAL INVESTIGATOR
Eili Huhtamo, PhD
Haartman Institute, University of Helsinki
- PRINCIPAL INVESTIGATOR
Olli Vapalahti, MD PhD
Haartman Institute, University of Helsinki
- PRINCIPAL INVESTIGATOR
Sari Pakkanen, MSc
Haartman Institute, University of Helsinki
- PRINCIPAL INVESTIGATOR
Sirkka Vene, BMA
Swedish Institute of Infectious Disease Control
- PRINCIPAL INVESTIGATOR
Jukka Riutta, MD
Travel clinic, Postitalo, Lääkärikeskus
- STUDY DIRECTOR
Anu Kantele, MD PhD
Helsinki University Central Hospital
- STUDY DIRECTOR
Lars Rombo, MD PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 30, 2011
First Posted
July 1, 2011
Study Start
January 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
October 28, 2011
Record last verified: 2011-10