HPVHPVAC2NCT05462249
Impact of Catch-up HPV Vaccination
An observational study of HPV and HPV Vaccination, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, HPV Vaccination, Vaccine Preventable Disease
- Type of treatment
- Vaccines
- How many people
- 354 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between 25 and 38 years old in 2022 coming for a HPV or smear test during the study period.
Who may be able to join
- Age limit
- Patient must have done a HPV or smear test during the study period
- Consent necessary
Who cannot join
- Age limit
- No HPV or smear test done in the study period
- Patient not able to give her consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Medical subject headings
- Vaccine-Preventable Diseases, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Patients who have been vaccinated against HPV virus. | |
| Not vaccinated | Patients who have not been vaccinated against HPV virus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test HPV and smear test result.
Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old).
Measured: 13 months.
Secondary outcomes (4)
Test HPV and smear test result.
Study the effectiveness of anti-HPV vaccine (done between 11 and 15 years old).
Measured: 13 months.
Test HPV and smear test result.
Study the effectiveness of anti-HPV vaccine (not regarding the period of realization)
Measured: 13 months.
Test HPV and smear test result.
Compare the effectiveness of anti-HPV vaccine done before and after 15 years old.
Measured: 13 months.
Test HPV and smear test result regarding the cervical cancer risk factors.
Study the impact of the known cervical cancer risk factors on the smear results.
Measured: 13 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start21 May 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: overestimation of the number of healthcare professionals participating in the inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe MERVIEL, PU-PH, Study director, Head of the gynecologic department in Brest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462249
- Sponsor's protocol ID
- HPVAC2 - 29BRC21.0008
- Acronym
- HPVAC2
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data are anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Catch-up HPV Vaccination on the Development of Cervical Lesions
- ClinicalTrials.gov ID
- NCT05462249
- Acronym / sponsor ID
- HPVAC2 / HPVAC2 - 29BRC21.0008
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: overestimation of the number of healthcare professionals participating in the inclusions
- Enrolment
- 354 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | –Patients who have been vaccinated against HPV virus. |
| Not vaccinated | – | –Patients who have not been vaccinated against HPV virus. |
Who may qualify
- Ages
- 25 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between 25 and 38 years old in 2022 coming for a HPV or smear test during the study period.
Key inclusion criteria (3 listed)
- Age limit
- Patient must have done a HPV or smear test during the study period
- Consent necessary
Key exclusion criteria (3 listed)
- Age limit
- No HPV or smear test done in the study period
- Patient not able to give her consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test HPV and smear test result.
Time frame: 13 months.
Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old).
4 secondary outcomes
Test HPV and smear test result.
Time frame: 13 months.
Test HPV and smear test result.
Time frame: 13 months.
Test HPV and smear test result.
Time frame: 13 months.
Test HPV and smear test result regarding the cervical cancer risk factors.
Time frame: 13 months.
Results and safety
The study was stopped early (reason given: overestimation of the number of healthcare professionals participating in the inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No. All the data are anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe MERVIEL, PU-PH study director
Head of the gynecologic department in Brest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV and HPV Vaccination, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: overestimation of the number of healthcare professionals participating in the inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test HPV and smear test result. (time frame: 13 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.