Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT01914367
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C510352', 'term': 'human papillomavirus vaccine, L1 type 16, 18'}, {'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D053918', 'term': 'Papillomavirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2013-08-01', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing of VDJ and VJ segments in the immunoglobulin heavy and light chains/plasmablasts', 'timeFrame': 'at day 187'}, {'measure': 'comparing the mutational diversity that occurs following vaccine-induced affinity maturation in plasmablasts', 'timeFrame': 'at day 187'}], 'secondaryOutcomes': [{'measure': 'evaluation of the cross-reactive pattern of polyclonal serum antibodies', 'timeFrame': 'at day 187'}, {'measure': 'comparing of VDJ and VJ segment usage and affinity maturation in HPV-specific antibodies', 'timeFrame': 'at day 187'}, {'measure': 'comparing of the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light (VL) chains from single ASC', 'timeFrame': 'at day 187'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection With Human Papillomavirus']}, 'descriptionModule': {'briefSummary': 'Six identical female twins aged 9-13 years will participate. One sib of each twin pair will be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood samples will be taken (the first prior to vaccine administration, the second and third 7 days after dose 2 and 3, respectively). The blood samples will be used to determine: 1) the magnitude the anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the cross-reactive pattern of these responses towards related, non-vaccine HPV strains (HPV-31 and -33, and HPV-45). 3) plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and eventually after the 2nd dose also) will be examined for for the usage of VDJ and VJ segments in the immunoglobulin heavy (VH) and light (VL) heavy and light chains. Gene useg in B cells induced by Cervarix and Gardasil will be compared. Finally the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light (VL) chains from single ASC isolated after the 3rd dose of a three-dose schedule of either Cervarix or Gardasil will be examined.\n\nThe duration of the study is approximately 187 days. Five study visits will take place, over a time period of 6.5 months, followed by a telephone call after 12 months.\n\nThe purpose of the study is to learn more about the molecular mechanisms underlying the cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Six homozygous twins in good health, without preceding sexual activity (virgin). Subjects have a negative pregnancy test on the day of vaccination and have agreed to continue abstinence during the entire study period and for two months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Subjects are not participating in any other clinical trials and have not been vaccinated previously against HPV and have not had an administration of MPL or AS04 in the past.'}, 'identificationModule': {'nctId': 'NCT01914367', 'acronym': 'HPVXneutra001', 'briefTitle': 'Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)', 'orgStudyIdInfo': {'id': '2013/422'}, 'secondaryIdInfos': [{'id': '2013-002340-90', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cervarix group', 'description': 'One sib of each twin pair will be given Cervarix according to the 0, 1, 6 month vaccination scheme.', 'interventionNames': ['Biological: cervarix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gardasil Group', 'description': 'One sib of each twin pair will be given Gardasil according to the 0, 1, 6 month vaccination scheme.', 'interventionNames': ['Biological: Gardasil']}], 'interventions': [{'name': 'cervarix', 'type': 'BIOLOGICAL', 'otherNames': ["GSK's commercially available bivalent HPV types 16 and 18 recombinant vaccine containing AS04 adjuvant (Cervarix®)"], 'description': '3 doses will be given, one on Day 0, one on Day 30 and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm', 'armGroupLabels': ['Cervarix group']}, {'name': 'Gardasil', 'type': 'BIOLOGICAL', 'otherNames': ["Merck's commercially availably quadrivalent HPV(types 6, 11, 16, 18) recombinant vaccine containing amorphous aluminiumhydroxyphosphate sulphate adjuvant"], 'description': '3 doses will be given, one on Day 0, one on Day 60 ± 2 days and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm', 'armGroupLabels': ['Gardasil Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Geert Leroux-Roels, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}