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

Terminated

• Conditions: Catch-up Vaccination; HPV Vaccination; Cervical Cancer; Pap Smear

• Registration Number: NCT03328013
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2017-12-04
• Status Verified: 2021-10
• Primary Completion: 2021-10-19
• Study Completion: 2021-10-19
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 191

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France