Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 11:30 AM
Study NCT ID:
NCT07303751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D065310', 'term': 'Squamous Intraepithelial Lesions of the Cervix'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is randomized trial with two arms. First arm will receive one dose of the nonavalent vaccine and the second unvaccined arm will serve as a control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in infective capacity of cervical HPV virions at 6 months, between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).', 'timeFrame': '7 months', 'description': 'To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).'}], 'secondaryOutcomes': [{'measure': 'The difference in the HPV neutralization capacity of vaccine-induced antibodies in serum and cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine', 'timeFrame': '7 months', 'description': 'To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).'}, {'measure': 'The difference in HPV viral load in cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).', 'timeFrame': '7 months', 'description': 'To analyse the differences in the HPV viral load in cervical samples at 6 months between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).'}, {'measure': 'Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples', 'timeFrame': '7 months', 'description': 'To analyse urine samples at month 6 to detect neutralizing antibodies to HPV 16, 18, 31, 33, 45, 52, 58, and the infective capacity of HPV 16, 18, 31, 33, 45, 52, 58 virions and to measure HPV 16, 18, 31, 33, 45, 52, 58 viral load'}, {'measure': 'The difference in infectivity reduction and vaccine induced antibodies among different HPV types.', 'timeFrame': '7 months', 'description': 'To analyse differences in infectivity reduction and vaccine induced antibodies among different HPV types included in the 9-valent vaccine.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical cancer', 'Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III)', 'Squamous Intraepithelial Lesions of the Cervix, High/ Low Grade', 'Human Papillomavirus (HPV) Infections', 'High-risk HPV', 'HPV-16/ 18', 'HPV DNA Tests', 'HPV Vaccines', 'HPV Nonavalent Vaccine', 'Gardasil-9', '9vHPV'], 'conditions': ['HPV', 'High-risk HPV (Any Strain)', 'Human Papillomavirus (HPV) Infections']}, 'referencesModule': {'references': [{'pmid': '29559436', 'type': 'BACKGROUND', 'citation': 'Hooper R, Forbes A, Hemming K, Takeda A, Beresford L. Analysis of cluster randomised trials with an assessment of outcome at baseline. BMJ. 2018 Mar 20;360:k1121. doi: 10.1136/bmj.k1121. No abstract available.'}, {'pmid': '26944311', 'type': 'BACKGROUND', 'citation': 'Houlihan CF, Baisley K, Bravo IG, Kapiga S, de Sanjose S, Changalucha J, Ross DA, Hayes RJ, Watson-Jones D. Rapid acquisition of HPV around the time of sexual debut in adolescent girls in Tanzania. Int J Epidemiol. 2016 Jun;45(3):762-73. doi: 10.1093/ije/dyv367. Epub 2016 Mar 4.'}, {'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. (2025, 6 de marzo). Human Papillomavirus (HPV) Vaccine Safety. https://www.cdc.gov/vaccine-safety/vaccines/hpv.html'}, {'pmid': '23486859', 'type': 'BACKGROUND', 'citation': 'Watson-Jones D, Baisley K, Brown J, Kavishe B, Andreasen A, Changalucha J, Mayaud P, Kapiga S, Gumodoka B, Hayes RJ, de Sanjose S. High prevalence and incidence of human papillomavirus in a cohort of healthy young African female subjects. Sex Transm Infect. 2013 Aug;89(5):358-65. doi: 10.1136/sextrans-2012-050685. Epub 2013 Mar 13.'}, {'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention. (2024, 9 de julio). HPV Vaccine Safety and Effectiveness Data. https://www.cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html'}, {'pmid': '25305210', 'type': 'BACKGROUND', 'citation': 'Chow EP, Read TR, Wigan R, Donovan B, Chen MY, Bradshaw CS, Fairley CK. Ongoing decline in genital warts among young heterosexuals 7 years after the Australian human papillomavirus (HPV) vaccination programme. Sex Transm Infect. 2015 May;91(3):214-9. doi: 10.1136/sextrans-2014-051813. Epub 2014 Oct 10.'}, {'pmid': '38873638', 'type': 'BACKGROUND', 'citation': 'Whitworth HS, Mounier-Jack S, Choi EM, Gallagher KE, Howard N, Kelly H, Mbwanji G, Kreimer AR, Basu P, Barnabas R, Drolet M, Brisson M, Watson-Jones D. Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials. Vaccine X. 2024 Apr 16;19:100486. doi: 10.1016/j.jvacx.2024.100486. eCollection 2024 Aug.'}, {'pmid': '34960159', 'type': 'BACKGROUND', 'citation': 'Kamolratanakul S, Pitisuttithum P. Human Papillomavirus Vaccine Efficacy and Effectiveness against Cancer. Vaccines (Basel). 2021 Nov 30;9(12):1413. doi: 10.3390/vaccines9121413.'}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '38567541', 'type': 'BACKGROUND', 'citation': 'Teblick L, Lipovac M, Molenberghs F, Delputte P, De Vos WH, Vorsters A. HPV-specific antibodies in female genital tract secretions captured via first-void urine retain their neutralizing capacity. Hum Vaccin Immunother. 2024 Dec 31;20(1):2330168. doi: 10.1080/21645515.2024.2330168. Epub 2024 Apr 3.'}, {'pmid': '35653138', 'type': 'BACKGROUND', 'citation': 'Smahelova J, Hamsikova E, Ludvikova V, Vydrova J, Traboulsi J, Vencalek O, Lukes P, Tachezy R. Outcomes After Human Papillomavirus Vaccination in Patients With Recurrent Respiratory Papillomatosis: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):654-661. doi: 10.1001/jamaoto.2022.1190.'}, {'pmid': '40047786', 'type': 'BACKGROUND', 'citation': 'Wenande E, Hastrup A, Wiegell S, Philipsen PA, Thomsen NB, Demehri S, Kjaer SK, Haedersdal M. Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial. JAMA Dermatol. 2025 Jun 1;161(6):605-614. doi: 10.1001/jamadermatol.2025.0531.'}, {'pmid': '31255301', 'type': 'BACKGROUND', 'citation': 'Drolet M, Benard E, Perez N, Brisson M; HPV Vaccination Impact Study Group. Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis. Lancet. 2019 Aug 10;394(10197):497-509. doi: 10.1016/S0140-6736(19)30298-3. Epub 2019 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16/18/31/33/45/52 or 58 can decrease the infectivity of shed HPV viruses.\n\nOur hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'We will enroll only ciswomen', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Born female\n* Aged between 18-29 years old;\n* Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;\n* Willing to participate in the study and have signed the informed consent form;\n* In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);\n* Willing to be tested for HIV;\n* Are HIV negative at the screening visit;\n* Not pregnant;\n* Able to pass a Test of Understanding (TOU);\n* Willing to provide cervical, urine and blood samples;\n* Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;\n* Have no visible suspicious cervical lesions on examination.\n* Agree to a pregnancy test at screening and before any HPV vaccination.\n\nExclusion Criteria:\n\n* They have been previously vaccinated against HPV;\n* They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;\n* They are HIV positive or immunocompromised;\n* They are pregnant or planning to get pregnant in the next 12 months;\n* They are less than three months post-partum or currently breastfeeding;\n* They are allergic to one of the vaccine components or to latex;\n* They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose\n* The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation."}, 'identificationModule': {'nctId': 'NCT07303751', 'acronym': 'RIFT-SSA', 'briefTitle': 'Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigació Biomèdica de Bellvitge"}, 'officialTitle': 'HPV Vaccination and Infectivity Reduction in HPV-positive Women', 'orgStudyIdInfo': {'id': 'INV-074218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervantional Arm', 'description': 'Women randomisied on this arm will receive their first dose at Month 0 (M0).', 'interventionNames': ['Biological: Nonavalent HPV vaccine (9vHPV)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Women randomised on this arm will not to be vaccinated at Month 0 (M0).'}], 'interventions': [{'name': 'Nonavalent HPV vaccine (9vHPV)', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil-9™'], 'description': "Nonavalent HPV vaccine (9vHPV/ Gardasil-9™). Sterile suspension, 0.5 ml dose, intramuscular, prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein from 9 HPV types: 6/11/16/18/31/33/45/52/58. 9vHPV is currently indicated in the EU in individuals from 9 years of age for the prevention of diseases caused by vaccine's 9 HPV types: genital warts (HPV6 and 11) and premalignant lesions and cancers affecting the cervix, vulva, vagina and anus (HPV16, 18, 31, 22, 45, 52 and 58). It was authorized for marketing in the EU on June 9th, 201", 'armGroupLabels': ['Intervantional Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freetown', 'country': 'Sierra Leone', 'contacts': [{'name': 'Daniel Tindanbil', 'role': 'CONTACT', 'email': 'Daniel.Tindanbil@lshtm.ac.uk', 'phone': '+232-33634212'}], 'facility': 'Kambia Research Centre', 'geoPoint': {'lat': 8.48714, 'lon': -13.2356}}], 'centralContacts': [{'name': 'Miquel Àngel Pavón Ribas PhD', 'role': 'CONTACT', 'email': 'mpavon@iconcologia.net', 'phone': '+34932607123'}, {'name': 'Elena Ruiz Puig', 'role': 'CONTACT', 'email': 'eruiz@idibell.cat'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut d'Investigació Biomèdica de Bellvitge", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Infection and Cancer Laboratory. Principal Investigator-PHD', 'investigatorFullName': 'Miquel Angel Pavon Ribas', 'investigatorAffiliation': "Institut d'Investigació Biomèdica de Bellvitge"}}}}