Impact of HPV Vaccination to Catch up in the Emergence of Lesions of the Cervix (HPVAC)

October 19, 2021 updated by: University Hospital, Brest

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In France, the vaccination coverage observed for HPV vaccination is low for a full-scale regimen, and has been falling since 2010. A high rate of HPV vaccination coverage has a significant epidemiological impact with a reduction in cervical cancer mortality.

There is less data on vaccinated catch-up patients. In 2017, these patients are 25 years of age or older and carry out screening smears.

The aim of this study is to demonstrate whether HPV catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients.

If so, these data will help mobilize doctors to vaccinate patients against HPV, even in catching-up.

Study Overview

Status

Terminated

Conditions

Detailed Description

In France, the observed vaccination coverage is very low for a complete regimen and has been declining since 2010. This low coverage makes it impossible to benefit from the efficiency observed in the other countries.

Indeed, a high HPV vaccination coverage rate would allow an epidemiologically significant impact with a reduction in cervical cancer mortality. In France, it is estimated that the vaccination of 80% of girls between the ages of 11 and 14 would reduce the incidence of 72% of CIN2 and 54% of CIN3.

Nevertheless, there is less data on patients who have been vaccinated in catch-up. These patients are 25 years of age or older in 2017, and make smears.

The aim of this study is to demonstrate whether HPV catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients.

If our study shows the benefits of catch-up vaccination, these data will help to mobilize doctors to vaccinate girls 15-19 years of age against HPV if they have not been able to benefit between 11 and 14 years as recommended.

Study Type

Observational

Enrollment (Actual)

191

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
      • Brest, France, 29609
        • 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 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women, aged 25 to 33 in 2017, with a smear analyzed at the Brest University Hospital, vaccinated or not against HPV

Description

Inclusion Criteria:

  • women
  • aged 25 to 33 in 2017
  • with a smear analyzed at the Brest University Hospital

Exclusion Criteria:

  • men
  • age over 33 years or less than 25 years
  • patient refusing to participate

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

Cohorts and Interventions

Group / Cohort
Women aged 25 to 33 years in 2017

Women aged 25 to 33 years in 2017 and having performed an analyzed smear at the Brest University Hospital.

They are invited to fill out an online questionnaire asking them about :

  • vaccine status against HPV
  • if vaccinated, the name of the vaccine and the number of injection
  • age of first sexual intercourse
  • do they have a gynecological pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
age of occurrence of lesions according to the year of vaccination
Time Frame: Day 1 (questionnaire completed by patient)
Day 1 (questionnaire completed by patient)
number of injection received
Time Frame: Day 1 (questionnaire completed by patient)
Day 1 (questionnaire completed by patient)
Age of onset of sexual activity
Time Frame: Day 1 (questionnaire completed by patient)
Day 1 (questionnaire completed by patient)
Vaccine received
Time Frame: Day 1 (questionnaire completed by patient)
Day 1 (questionnaire completed by patient)

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

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.

General Publications

Helpful Links

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)

December 4, 2017

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

October 19, 2021

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPVAC (29BRC17.0086)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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