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Not yet taking people in ItalyPhase 3

Tests HPV vaccine to reduce cervical disease returning after surgery

Tests an HPV vaccine against placebo in women treated for cervical precancer.

Key facts

Who runs it
Alessandro Ghelardi
Where
Alba, Massa, Milan, Naples, Palermo, Rome, and Treviso, ItalySee the 9 sites
Registry title
Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9
Status
Not yet recruiting
Phase
Phase 3
People taking part
1,220 people, planned
Started
Dec 2020
Expected to end
May 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Gardasil-9
  • Placebo
Record updated
5 November 2020

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 or older with high-grade cervical precancer or very early cervical cancer, planned for LEEP surgery. It tests whether a 9-valent HPV vaccine given before surgery lowers the chance of the disease coming back.

Age
18 years or older
Sex
Women only
Disease stage
High-grade cervical intraepithelial neoplasia (CIN2 or worse) or initially invasive cervical cancer (up to stage Ia1 by FIGO staging)
Earlier treatment
No previous HPV vaccination. No immunoglobulins or blood products in the 3 months before vaccination.

Main reasons for not taking part

  • Taking immunosuppressive therapy
  • Positive pregnancy test at the time of vaccination
  • Allergic reaction or serious side effects to a previous vaccination
  • Platelet shortage or other clotting disorder that could cause bleeding after an injection into the muscle
  • ECOG performance status of 2 or higher

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Patients aged ≥ 18 and ecog performance status ≤ 1
  • Patients with a diagnosis of high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological results ≥ CIN2 + and ≤ Ia1 according to the FIGO staging of cervical cancer)
  • No fever at the time of vaccination
  • No previous HPV vaccination
  • Ability to understand and write Italian
  • Signed informed and privacy consent

Who cannot take part

  • History of allergic reaction or serious adverse events to previous vaccinations
  • Patient in treatment with immunosuppressive therapy
  • Subjects who received immunoglobulins or blood products in 3 months prior to vaccination
  • Clinical criteria contraindicating the surgical act of conization
  • Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration
  • Patients enrolled in other clinical studies
  • Positive pregnancy test at the time of vaccination
  • ECOG performance status ≥2

Where in Italy

  • Azienda Sanitaria Locale Cn2 Alba-BraAlba, ItalyNo longer taking part
  • Azienda Unita Sanitaria Locale Toscana Nord OvestMassa, ItalyNo longer taking part
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNo longer taking part
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyNo longer taking part
  • Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
  • Istituto Nazionale dei Tumori,Naples, ItalyNo longer taking part
  • Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyNo longer taking part
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNo longer taking part
  • Azienda Unita' Locale Socio Sanitaria N. 2 Marca TrevigianaTreviso, ItalyNo longer taking part

About the trial

What the trial wants to find out

This study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.

The 2 groups in the trial

  • Gardasil-9Treatment being tested

    Intramuscular Gardasil-9 vaccination at 0, 2 and 6 months.

  • PlaceboPlacebo, for comparison

    Placebo injection at 0, 2 and 6 months

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomised, Double-Blind, Placebo-Controlled, Phase III Study to Investigate the Efficacy of Presurgical 9-valent HPV Vaccination in Women Treated With LEEP for CIN 2+ and Initially Invasive Cervical Cancer.
Plain-language title
Tests HPV vaccine to reduce cervical disease returning after surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 November 2020