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

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Anu Kantele, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01386827
First received: June 30, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Japanese Encephalitis
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Antibody titers 1 month after last vaccine dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Determination of antibody titers 1 month after last vaccine dose


Secondary Outcome Measures:
  • Antibody titers two years after vaccination [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measurement of antibody titers two years after vaccination


Enrollment: 120
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A) primary immunization with MB-JEV
Volunteers immunized with MB-JEV
Biological: 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
Other Name: Korean Green Cross
Active Comparator: Primary and booster MBJEV vaccinations
Booster immunization with MB-JEV of vaccinees primed with MB-JEV
Biological: 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
Other Name: Korean Green Cross
Active Comparator: C) primary immunizations with Ixiaro
Primary immunization with Ixiaro 2 dose
Biological: C) primary immunizations with Ixiaro
2 0.5 ml doses of Ixiaro 28 days apart
Other Name: Ixiaro
Active Comparator: S) Ixiaro booster to MBJEV primed
Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV
Biological: S) Ixiaro booster to MBJEV primed
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
Other Name: Ixiaro

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386827

Sponsors and Collaborators
Helsinki University Central Hospital
Karolinska Institutet
Investigators
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
  More Information

No publications provided by Helsinki University Central Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anu Kantele, Associate professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01386827     History of Changes
Other Study ID Numbers: 382/E7/07
Study First Received: June 30, 2011
Last Updated: October 27, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
Ixiaro
japanese encephalitis vaccine
booster

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalitis
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014