NCT03848039

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,220

participants targeted

Target at P75+ for phase_3

Timeline
24mo left

Started Dec 2020

Longer than P75 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Dec 2020May 2028

First Submitted

Initial submission to the registry

February 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Expected
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

February 19, 2019

Last Update Submit

November 4, 2020

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Cervical Cancercervical intraepithelial neoplasiaPapillomavirus Vaccines

Outcome Measures

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

    5 years after surgical treatment

Secondary Outcomes (2)

  • impact of the vaccine on prevalent post-surgery infections

    5 years after surgical treatment

  • 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

    5 years after surgical treatment

Study Arms (2)

Gardasil-9

EXPERIMENTAL

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

Biological: Gardasil-9

Placebo

PLACEBO COMPARATOR

Placebo injection at 0, 2 and 6 months

Drug: Placebo

Interventions

Gardasil-9BIOLOGICAL

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

Also known as: 9-valent HPV vaccine, Vaccine against HPV-6, 11, 16, 18, 31, 33, 45, 52, 58
Gardasil-9
PlaceboDRUG

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

Also known as: Sterile Water for Injection Ph. Eur.
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Subjects who received immunoglobulins or blood products in 3 months prior to vaccination.
  • Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration
  • Clinical criteria contraindicating the surgical act of conization
  • ECOG performance status ≥2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • Alessandro Ghelardi, MD

    Az. USL Toscana Nord Ovest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Ghelardi, MD

CONTACT

+39 0585 6571alessandro.ghelardi@uslnordovest.toscana.it

Paola Bay, MD

CONTACT

+39 0585 6571paola.bay@uslnordovest.toscana.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Department of Obstetrics and Gynaecology Azienda USL Toscana Nord Ovest, Presidio Ospedaliero delle Apuane (MS)- Italy

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 20, 2019

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion (Estimated)

May 1, 2028

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share