Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-20 @ 11:28 AM
Study NCT ID:
NCT02236234
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053918', 'term': 'Papillomavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Anti-HPV antibody titers', 'timeFrame': '0, 30 and 180 days of vaccination anti-HPV', 'description': 'The anti-HPV titers will be compared from baseline to the date of sample collection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'HPV', 'Clinical trial', 'outcome'], 'conditions': ['Infection']}, 'descriptionModule': {'briefSummary': 'Besides the specific response to vaccine antigens, the investigators will analyze the anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess the range of the count with the highest possibility of vaccine response. Thus, knowledge of vaccine response in HIV-infected patients, indicate which patients would have greater potential for vaccine response in vivo.', 'detailedDescription': 'The study will be divided into three groups. Patients with HIV-1 infection will be subdivided into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells count and bellow 500 CD4 T cells count. A healthy control group will be also studied.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: HIV\n\n* Men with age between 35 and 45 years of age.\n\nExclusion Criteria:\n\n* Current or previous infection with human papillomavirus (HPV)'}, 'identificationModule': {'nctId': 'NCT02236234', 'acronym': 'HPV', 'briefTitle': 'Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil', 'orgStudyIdInfo': {'id': '2010/07076-4'}, 'secondaryIdInfos': [{'id': 'FAPESP', 'type': 'OTHER_GRANT', 'domain': '2010/07076-4'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine', 'description': 'one group with HPV vaccine', 'interventionNames': ['Biological: HPV vaccine']}], 'interventions': [{'name': 'HPV vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['cerverix'], 'description': 'HPV vaccine', 'armGroupLabels': ['Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Institute of Tropical Medicine of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'jorge casseb, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Jorge Casseb', 'investigatorAffiliation': 'University of Sao Paulo'}}}}