Impact of Catch-up HPV Vaccination (HPVAC2)

April 28, 2025 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- Finistère
  - Brest, Finistère, France, 29000
    - CHU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women between 25 and 38 years old in 2022 coming for a HPV or smear test during the study period.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Vaccinated Patients who have been vaccinated against HPV virus.
Not vaccinated Patients who have not been vaccinated against HPV virus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test HPV and smear test result. Time Frame: 13 months.	Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old).	13 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

HPV Vaccination and the Risk of Invasive Cervical Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

HPVAC2 - 29BRC21.0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

All the data are anonymized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.