NCT07431502

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 984 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BioHPV is a randomized, double-blinded, placebo-controlled, multi-center, phase III trial evaluating nonavalent HPV (9vHPV) vaccine in 984 patients aged ≤55 undergoing HSIL treatment at any site (gynecological (i.e. vulvar, vaginal, cervical), anal, penile).

Conditions

• 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 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 Anal Site

Interventions

Type	Name	Description
BIOLOGICAL	HPV vaccine	HPV vaccine, 3 timepoints : month 0, month 1-2, month 6
BIOLOGICAL	Placebo vaccine	Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-11-01
• Completion: 2030-11-01
• First posted: 2026-02-24
• Last updated: 2026-02-27