Ignite Creation Date:
2025-12-25 @ 1:00 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT01286493
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2011-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011818', 'term': 'Rabies'}], 'ancestors': [{'id': 'D018353', 'term': 'Rhabdoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sudapunrin@gmail.com', 'phone': '+66 2 2520161', 'title': 'Dr.Suda Sibunruang', 'phoneExt': '125', 'organization': 'Queen Saovabha Memorial Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small sample size heterogeneous characteristics of participants Use only CD4+ T lymphocyte counts as the only immunologic surrogate marker'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Rabies Vaccines on Day 0 and 3', 'description': 'Cell culture Rabies vaccines on day 0 and 3\n\nrabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rabies Neutralizing Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rabies Vaccines on Day 0 and 3', 'description': 'Cell culture Rabies vaccines on day 0 and 3\n\nrabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360'}], 'classes': [{'categories': [{'measurements': [{'value': '8.48', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '218.10'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 360', 'description': 'Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.\n\nfor 7 times in 1 year.', 'unitOfMeasure': 'IU/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'As preliminary study, the number of participants was estimated to be above 15 - 20 cases.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rabies Vaccines on Day 0 and 3', 'description': 'Cell culture Rabies vaccines on day 0 and 3\n\nrabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rabies Vaccines on Day 0 and 3', 'description': 'Cell culture Rabies vaccines on day 0 and 3\n\nrabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Thailand', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4+ T lymphocyte counts', 'classes': [{'categories': [{'measurements': [{'value': '489', 'groupId': 'BG000', 'lowerLimit': '94', 'upperLimit': '1120'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cell/mm^3', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Preliminary study'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2011-01-26', 'resultsFirstSubmitDate': '2014-04-21', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-18', 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rabies Neutralizing Antibody Titers', 'timeFrame': 'Day 360', 'description': 'Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.\n\nfor 7 times in 1 year.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'booster', 'rabies', 'immune response'], 'conditions': ['HIV', 'Rabies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.saovabha.com', 'label': 'http://www.saovabha.com/th/academic.asp'}]}, 'descriptionModule': {'briefSummary': 'Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.', 'detailedDescription': 'The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected patients 18-60 years of age\n* Ever received primary rabies immunization\n\nExclusion Criteria:\n\n* currently have any active opportunistic infections\n* have received blood or blood product within previous 3 months\n* history of allergy to vaccine or any vaccine components\n* currently received anti-malarial drugs'}, 'identificationModule': {'nctId': 'NCT01286493', 'briefTitle': 'Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Queen Saovabha Memorial Institute'}, 'officialTitle': 'Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination', 'orgStudyIdInfo': {'id': 'RC5303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rabies vaccines on day 0 and 3', 'description': 'Cell culture Rabies vaccines on day 0 and 3', 'interventionNames': ['Biological: rabies vaccines on day 0 and 3']}], 'interventions': [{'name': 'rabies vaccines on day 0 and 3', 'type': 'BIOLOGICAL', 'description': 'All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360', 'armGroupLabels': ['Rabies vaccines on day 0 and 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Queen Saovabha Memorial Institute', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Suda Sibunruang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Saovabha Memorial Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Saovabha Memorial Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Suda Sibunruang', 'investigatorAffiliation': 'Queen Saovabha Memorial Institute'}}}}