HPVAC2: Impact of Catch-up HPV Vaccination

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT05462249

Collaborator

(none)

354

Enrollment

Location

13.3

Actual Duration (Months)

26.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. Therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed.

HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up HPV vaccination.

Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to do their regular cervical smear. At this time, a survey will be given to know their vaccinal status.

The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.

Condition or Disease	Intervention/Treatment	Phase
HPV HPV Vaccination Vaccine Preventable Disease Cervical Lesion Cervical Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

354 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Impact of Catch-up HPV Vaccination on the Development of Cervical Lesions

Actual Study Start Date :

May 21, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Vaccinated Patients who have been vaccinated against HPV virus.
Not vaccinated Patients who have not been vaccinated against HPV virus.

Outcome Measures

Primary Outcome Measures

Test HPV and smear test result. [13 months.]
Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old).

Secondary Outcome Measures

Test HPV and smear test result. [13 months.]
Study the effectiveness of anti-HPV vaccine (done between 11 and 15 years old).
Test HPV and smear test result. [13 months.]
Study the effectiveness of anti-HPV vaccine (not regarding the period of realization)
Test HPV and smear test result. [13 months.]
Compare the effectiveness of anti-HPV vaccine done before and after 15 years old.
Test HPV and smear test result regarding the cervical cancer risk factors. [13 months.]
Study the impact of the known cervical cancer risk factors on the smear results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age limit
Patient must have done a HPV or smear test during the study period
Consent necessary

Exclusion Criteria:

Age limit
No HPV or smear test done in the study period
Patient not able to give her consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de BREST	Brest	Finistère	France	29000

Sponsors and Collaborators

University Hospital, Brest

Investigators

Study Director: Philippe MERVIEL, PU-PH, Head of the gynecologic department in Brest Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

HPV Vaccination and the Risk of Invasive Cervical Cancer

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT05462249

Other Study ID Numbers:

HPVAC2 - 29BRC21.0008

First Posted:

Jul 18, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vaccine-Preventable Diseases

Study Results

No Results Posted as of Jul 18, 2022