Impact of Catch-up HPV Vaccination

NCT05462249 | Terminated

• 1 other identifier: HPVAC2 - 29BRC21.0008
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV; HPV Vaccination; Vaccine Preventable Disease; Cervical Lesion; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Test HPV and smear test result.

  Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old).

  13 months.

Secondary Outcomes (4)

• Test HPV and smear test result.

  13 months.

• Test HPV and smear test result.

  13 months.

• Test HPV and smear test result.

  13 months.

• Test HPV and smear test result regarding the cervical cancer risk factors.

  13 months.

Study Arms (2)

Vaccinated

Patients who have been vaccinated against HPV virus.

Not vaccinated

Patients who have not been vaccinated against HPV virus.

Eligibility Criteria

• Age: 25 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de BREST

Brest, Finistère, 29000, France

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Infections; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Philippe MERVIEL, PU-PH

  Head of the gynecologic department in Brest Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 18, 2022
• Study Start: May 21, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)