Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alessandro Ghelardi
• Treatments: Vaccines

Criteria

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