Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar SitePhase 3BioHPVNCT07431502
Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions
A Phase 3 study testing HPV vaccine in people with Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site and Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site, run by Gustave Roussy, Cancer Campus, Grand Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- 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
- What is being tested?
- HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 984 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Nov 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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
- Being tested
- HPV vaccine, Placebo vaccine
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineBiological
HPV vaccine, 3 timepoints : month 0, month 1-2, month 6
Placebo vaccineBiological
Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo vaccination, 3 timepoints Receives: Biological: Placebo vaccine |
| HPV Vaccine | Experimental | HPV vaccination, 3 timepoints Receives: Biological: HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar SiteStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 984 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Michels, MD PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431502
- Sponsor's protocol ID
- 2024-520140-42-00
- Acronym
- BioHPV
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07431502
- Acronym / sponsor ID
- BioHPV / 2024-520140-42-00
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 984 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo vaccinePlacebo vaccination, 3 timepoints |
| HPV Vaccine | Experimental | Biological: HPV vaccineHPV vaccination, 3 timepoints |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV vaccineHPV vaccine, 3 timepoints : month 0, month 1-2, month 6 | Biological | HPV Vaccine |
| Placebo vaccinePlacebo vaccine, 3 timepoints : month 0, month 1-2, month 6 | Biological | Placebo |
Primary outcome
Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.
Time frame: 4.5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Michels, MD PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HPV vaccine in people with Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site and Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site, run by Gustave Roussy, Cancer Campus, Grand Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie Lecerf, MSc (+33 42 11 42 11, elodie.lecerf@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed. (time frame: 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.