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

NCT07431502 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2026-02-27

No results posted yet for this study

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 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

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

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Judith Michels, MD PhD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-11-30
Completion
2030-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07431502 on ClinicalTrials.gov