Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions

NCT07431502 | Not Yet Recruiting Phase 3

• 1 other identifier: 2024-520140-42-00
• Study Type: interventional
• Target: 984
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, placebo-controlled phase 3 trial to evaluate nonavalent HPV vaccine as a secondary prevention in patients treated for human papilloma virus related high-grade squamous intraepithelial lesions.

Conditions

Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Penile Site; Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Cervical Site; Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site; Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site; Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Anal Site

Outcome Measures

Primary Outcomes (1)

• Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.

  To assess the efficacy of Human papilloma virus (HPV) vaccination as secondary prevention in patients with gynecological or anal HSIL.The endpoint will be the time to HPV type-specific recurrence of HSIL at the initial site after completed HSIL treatment.

  4.5 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo vaccination, 3 timepoints

Biological: Placebo vaccine

HPV Vaccine

EXPERIMENTAL

HPV vaccination, 3 timepoints

Biological: HPV vaccine

Interventions

HPV vaccine BIOLOGICAL

HPV vaccine, 3 timepoints : month 0, month 1-2, month 6

HPV Vaccine

Placebo vaccine BIOLOGICAL

Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women, men, transgender,18 ≤age ≤55
• ECOG performance status ≤ 1
• Patients infected with HIV are eligible for the study provided they are receiving antiretroviral therapy with undetectable viral load.
• Biopsy-proven HPV related HSIL at any site (vulvar VIN, vaginal VaIN, cervical CIN, anal AIN, penile PeIN) at baseline.
• Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the administration of the first vaccine injection.
• Sexually active patients must agree to use acceptable and appropriate contraception while included in BIO-HPV study and until the last dose of vaccine.
• Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
• Patients must be affiliated to a social security system or beneficiary of the same
• Life expectancy of greater than 5 years

You may not qualify if:

• History of HPV related cancer (i.e. anal, genital, head and neck, cutaneous, penile)
• History of prior treatment of HSIL
• Warts so extensive that they preclude the clinician from determining the extent and location of HSIL Prior HPV vaccination
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of trial treatment.
• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
• Prior malignancy active within the previous 3 years except from cancers with an expected PFS at 5 years of \>95%.
• Hypersensitivity to the active substances or to any of the excipients (Listed in the SmPC).
• Acute or severe febrile illness. Vaccination must be postponed until the individual has fully recovered.
• Pregnant women or intent to become pregnant
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Judith Michels, MD PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie Lecerf, MSc

CONTACT

+33 42 11 42 11; elodie.lecerf@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02