Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
NCT ID: NCT07303751
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2026-02-01
2027-02-01
Brief Summary
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Our 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervantional Arm
Women randomisied on this arm will receive their first dose at Month 0 (M0).
Nonavalent HPV vaccine (9vHPV)
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
Control Arm
Women randomised on this arm will not to be vaccinated at Month 0 (M0).
No interventions assigned to this group
Interventions
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Nonavalent HPV vaccine (9vHPV)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged between 18-29 years old;
* Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;
* Willing to participate in the study and have signed the informed consent form;
* In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);
* Willing to be tested for HIV;
* Are HIV negative at the screening visit;
* Not pregnant;
* Able to pass a Test of Understanding (TOU);
* Willing to provide cervical, urine and blood samples;
* Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;
* Have no visible suspicious cervical lesions on examination.
* Agree to a pregnancy test at screening and before any HPV vaccination.
Exclusion Criteria
* They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
* They are HIV positive or immunocompromised;
* They are pregnant or planning to get pregnant in the next 12 months;
* They are less than three months post-partum or currently breastfeeding;
* They are allergic to one of the vaccine components or to latex;
* 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
* The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.
18 Years
29 Years
FEMALE
No
Sponsors
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Miquel Angel Pavon Ribas
OTHER
Responsible Party
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Miquel Angel Pavon Ribas
Head of the Laboratory of Infections and Cancer (INCALAB)
Locations
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Kambia Research Centre
Freetown, , Sierra Leone
Countries
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Central Contacts
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Facility Contacts
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Daniel Tindanbil
Role: primary
References
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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.
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.
Centers for Disease Control and Prevention. (2025, 6 de marzo). Human Papillomavirus (HPV) Vaccine Safety. https://www.cdc.gov/vaccine-safety/vaccines/hpv.html
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.
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
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.
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.
Kamolratanakul S, Pitisuttithum P. Human Papillomavirus Vaccine Efficacy and Effectiveness against Cancer. Vaccines (Basel). 2021 Nov 30;9(12):1413. doi: 10.3390/vaccines9121413.
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.
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.
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.
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.
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.
Other Identifiers
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INV-074218
Identifier Type: -
Identifier Source: org_study_id