Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis
NCT ID: NCT01386827
Last Updated: 2011-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2008-01-31
2011-04-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A) primary immunization with MB-JEV
Volunteers immunized with MB-JEV
Mouse brain derived japanese encephalitis vaccine (MB-JEV)
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
Primary and booster MBJEV vaccinations
Booster immunization with MB-JEV of vaccinees primed with MB-JEV
Primary and booster immunizations with MB-JEV
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
C) primary immunizations with Ixiaro
Primary immunization with Ixiaro 2 dose
C) primary immunizations with Ixiaro
2 0.5 ml doses of Ixiaro 28 days apart
S) Ixiaro booster to MBJEV primed
Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV
S) Ixiaro booster to MBJEV primed
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
Interventions
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Mouse brain derived japanese encephalitis vaccine (MB-JEV)
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
Primary and booster immunizations with MB-JEV
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
C) primary immunizations with Ixiaro
2 0.5 ml doses of Ixiaro 28 days apart
S) Ixiaro booster to MBJEV primed
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
Yes
Sponsors
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Karolinska Institutet
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Anu Kantele
Associate professor
Principal Investigators
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Elina Erra, MD
Role: PRINCIPAL_INVESTIGATOR
Haartman Institute, University of Helsinki
Lars Lindqvist, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of infectious diseases Stockholm, Sweden
Eili Huhtamo, PhD
Role: PRINCIPAL_INVESTIGATOR
Haartman Institute, University of Helsinki
Olli Vapalahti, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Haartman Institute, University of Helsinki
Sari Pakkanen, MSc
Role: PRINCIPAL_INVESTIGATOR
Haartman Institute, University of Helsinki
Sirkka Vene, BMA
Role: PRINCIPAL_INVESTIGATOR
Swedish Institute of Infectious Disease Control
Jukka Riutta, MD
Role: PRINCIPAL_INVESTIGATOR
Travel clinic, Postitalo, Lääkärikeskus
Anu Kantele, MD PhD
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Lars Rombo, MD PhD
Role: STUDY_DIRECTOR
Karolinska Institutet
References
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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.
Other Identifiers
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382/E7/07
Identifier Type: -
Identifier Source: org_study_id