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

Malvacdecision.Net

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03328013
Acronym
HPVAC
Enrollment
191
Registered
2017-11-01
Start date
2017-12-04
Completion date
2021-10-19
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catch-up Vaccination, Cervical Cancer, HPV Vaccination, Pap Smear

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 33 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Nature of smear: normal or not (including ASCUS and AGC) according to their immunization statusDay 1

Secondary

MeasureTime frame
age of occurrence of lesions according to the year of vaccinationDay 1 (questionnaire completed by patient)
number of injection receivedDay 1 (questionnaire completed by patient)
Age of onset of sexual activityDay 1 (questionnaire completed by patient)
Vaccine receivedDay 1 (questionnaire completed by patient)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026