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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

ConditionsPatients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar SitePatients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal SitePatients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Penile SitePatients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Cervical SitePatients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Anal Site
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HPV vaccine

    Biological/Vaccine

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

  • Placebo vaccine

    Biological/Vaccine

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

Treatment groups

984 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: HPV VaccineExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
4.5 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: