Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT01386827
Status:
COMPLETED
Last Update Posted:
2011-10-28
First Post:
2011-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004672', 'term': 'Encephalitis, Japanese'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007117', 'term': 'Immunization, Secondary'}], 'ancestors': [{'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-27', 'studyFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2011-06-30', 'lastUpdatePostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody titers 1 month after last vaccine dose', 'timeFrame': '1 month', 'description': 'Determination of antibody titers 1 month after last vaccine dose'}], 'secondaryOutcomes': [{'measure': 'Antibody titers two years after vaccination', 'timeFrame': '2 years', 'description': 'Measurement of antibody titers two years after vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ixiaro', 'japanese encephalitis vaccine', 'booster'], 'conditions': ['Japanese Encephalitis']}, 'referencesModule': {'references': [{'pmid': '22696017', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTravellers 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female travellers ≥ 18 years of age.\n\n * General good health.\n * Written informed consent.\n * Ability to attend all visits scheduled in this study.\n * 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\n * 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.\n\nExclusion Criteria:\n\n* \\- \\< 18 years of age.\n* Acute disease at the time of enrollment.\n* Pregnancy or lactation.\n* Known immunodeficiency or immune suppressive treatment.\n* Any chronic illness that might interfere with the immune response; history of JE.\n* Alcohol or drug abuse.\n* Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement)."}, 'identificationModule': {'nctId': 'NCT01386827', 'briefTitle': 'Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '382/E7/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A) primary immunization with MB-JEV', 'description': 'Volunteers immunized with MB-JEV', 'interventionNames': ['Biological: Mouse brain derived japanese encephalitis vaccine (MB-JEV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary and booster MBJEV vaccinations', 'description': 'Booster immunization with MB-JEV of vaccinees primed with MB-JEV', 'interventionNames': ['Biological: Primary and booster immunizations with MB-JEV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C) primary immunizations with Ixiaro', 'description': 'Primary immunization with Ixiaro 2 dose', 'interventionNames': ['Biological: C) primary immunizations with Ixiaro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'S) Ixiaro booster to MBJEV primed', 'description': 'Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV', 'interventionNames': ['Biological: S) Ixiaro booster to MBJEV primed']}], 'interventions': [{'name': 'Mouse brain derived japanese encephalitis vaccine (MB-JEV)', 'type': 'BIOLOGICAL', 'otherNames': ['Korean Green Cross'], 'description': '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', 'armGroupLabels': ['A) primary immunization with MB-JEV']}, {'name': 'Primary and booster immunizations with MB-JEV', 'type': 'BIOLOGICAL', 'otherNames': ['Korean Green Cross'], 'description': '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', 'armGroupLabels': ['Primary and booster MBJEV vaccinations']}, {'name': 'C) primary immunizations with Ixiaro', 'type': 'BIOLOGICAL', 'otherNames': ['Ixiaro'], 'description': '2 0.5 ml doses of Ixiaro 28 days apart', 'armGroupLabels': ['C) primary immunizations with Ixiaro']}, {'name': 'S) Ixiaro booster to MBJEV primed', 'type': 'BIOLOGICAL', 'otherNames': ['Ixiaro'], 'description': '0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV', 'armGroupLabels': ['S) Ixiaro booster to MBJEV primed']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elina Erra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haartman Institute, University of Helsinki'}, {'name': 'Lars Lindqvist, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of infectious diseases Stockholm, Sweden'}, {'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': 'Haartman Institute, University of Helsinki'}, {'name': 'Sirkka Vene, BMA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Institute of Infectious Disease Control'}, {'name': 'Jukka Riutta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Travel clinic, Postitalo, Lääkärikeskus'}, {'name': 'Anu Kantele, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Lars Rombo, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Anu Kantele', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}