Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV

NCT07303751 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: INV-074218
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

HPV; High-risk HPV (Any Strain); Human Papillomavirus (HPV) Infections

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

Outcome Measures

Primary Outcomes (1)

• 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®).

  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®).

  7 months

Secondary Outcomes (4)

• 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

  7 months

• 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®).

  7 months

• Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples

  7 months

• The difference in infectivity reduction and vaccine induced antibodies among different HPV types.

  7 months

Study Arms (2)

Intervantional Arm

EXPERIMENTAL

Women randomisied on this arm will receive their first dose at Month 0 (M0).

Biological: Nonavalent HPV vaccine (9vHPV)

Control Arm

NO INTERVENTION

Women randomised on this arm will not to be vaccinated at Month 0 (M0).

Interventions

Nonavalent HPV vaccine (9vHPV) BIOLOGICAL

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

Also known as: Gardasil-9™

Intervantional Arm

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: We will enroll only ciswomen
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Born female
• 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.

You may not qualify if:

• They have been previously vaccinated against HPV;
• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead

Study Sites (1)

Kambia Research Centre

Freetown, Sierra Leone

Location

Related Publications (13)

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• Centers for Disease Control and Prevention. (2025, 6 de marzo). Human Papillomavirus (HPV) Vaccine Safety. https://www.cdc.gov/vaccine-safety/vaccines/hpv.html

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• 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.

  PMID: 23486859 BACKGROUND

• 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

  BACKGROUND

• 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: 25305210 BACKGROUND

• 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: 38873638 BACKGROUND

• 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: 34960159 BACKGROUND

• 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: 33538338 BACKGROUND

• 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: 38567541 BACKGROUND

• 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.

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  PMID: 31255301 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Infections; Uterine Cervical Neoplasms; Squamous Intraepithelial Lesions of the Cervix

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Cervical Dysplasia; Precancerous Conditions; Squamous Intraepithelial Lesions; Morphological and Microscopic Findings

Central Study Contacts

Miquel Àngel Pavón Ribas PhD

CONTACT

+34932607123; mpavon@iconcologia.net

Elena Ruiz Puig

CONTACT

eruiz@idibell.cat

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Infection and Cancer Laboratory. Principal Investigator-PHD

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 26, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SI (1)