Clinical trial · Interventional
Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9
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.
NCT03848039CI-TRIAL-00048113HOPE9not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil-9 | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gardasil-9
- description
- Intramuscular Gardasil-9 vaccination at 0, 2 and 6 months.
- interventionNames
- Biological: Gardasil-9
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo injection at 0, 2 and 6 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- evaluation of disease recurrence reduction (cervical intraepithelial neoplasia up to microinvasive cancer of the cervix)
- timeFrame
- 5 years after surgical treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged ≥ 18 and ecog performance status ≤ 1 2. 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) 3. No fever at the time of vaccination 4. No previous HPV vaccination 5. Ability to understand and write Italian 6. Signed informed and privacy consent Exclusion Criteria: 1. Patients enrolled in other clinical studies 2. History of allergic reaction or serious adverse events to previous vaccinations 3. Positive pregnancy test at the time of vaccination 4. Patient in treatment with immunosuppressive therapy 5. Subjects who received immunoglobulins or blood products in 3 months prior to vaccination. 6. Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration 7. Clinical criteria contraindicating the surgical act of conization 8. ECOG performance status ≥2
References
Publications (0)
Data not yet available
No reference posted for this study.