Health TrialsbyHealthPanel

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

ConditionCervical Intraepithelial Neoplasia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAlessandro Ghelardi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients enrolled in other clinical studies

History of allergic reaction or serious adverse events to previous vaccinations

Positive pregnancy test at the time of vaccination

Patient in treatment with immunosuppressive therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gardasil-9

    Biological/Vaccine

    administration by intramuscular injection of the 9-valent HPV vaccine according to a 3-dose vaccination schedule (0, 2, 6 months).

  • Placebo

    Drug

    administration by intramuscular injection of the placebo according to vaccination schedule of the 9-valent HPV vaccine (0, 2, 6 months)

Treatment groups

1,220 Participants
are divided into 2 treatment groups
Group A: Gardasil-9Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

evaluation of disease recurrence reduction (cervical intraepithelial neoplasia up to microinvasive cancer of the cervix)

evaluation of disease recurrence reduction (cervical intraepithelial neoplasia up to microinvasive cancer of the cervix) by comparing the number of recurrences in the two arms of the study

Time frame
5 years after surgical treatment

Secondary outcomes

1

impact of the vaccine on prevalent post-surgery infections

Analysis of the impact of the vaccine on prevalent post-surgery infections by comparing the prevalence of persistent HPV infections (duration greater than 12 months after surgery) in the two arms.

Time frame
5 years after surgical treatment
2

impact of the vaccine in the post-surgical surveillance times, comparison of viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic picture in the post-operative period

Analysis of the impact of the vaccine in the post-surgical surveillance times, comparison of the viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic picture in the post-operative period: comparison of the times of negativization overexposed in the two arms.

Time frame
5 years after surgical treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Alessandro Ghelardi

Lead sponsor

Azienda USL Toscana Nord Ovest

Sponsor institution

Source ClinicalTrials.gov

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