HPV VaccinationHPVACNCT03328013
Impact of HPV Vaccination to Catch up in the Emergence of Lesions of the Cervix
An observational study of HPV Vaccination and Pap Smear, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 33 years, women only
- Conditions the study is for
- HPV Vaccination, Pap Smear, Cervical Cancer
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 191 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2017to 19 Oct 2021
- 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 33 years
- Women only
- No healthy volunteers
- Adult
Study population: Women, aged 25 to 33 in 2017, with a smear analyzed at the Brest University Hospital, vaccinated or not against HPV
Who may be able to join
- women
- aged 25 to 33 in 2017
- with a smear analyzed at the Brest University Hospital
Who cannot join
- men
- age over 33 years or less than 25 years
- patient refusing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malvacdecision.Net
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.
Read the 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.
- Conditions
- HPV Vaccination, Pap Smear, Cervical Cancer, Catch-up Vaccination
- Medical subject headings
- 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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status
Measured: Day 1
Secondary outcomes (4)
age of occurrence of lesions according to the year of vaccination
Measured: Day 1 (questionnaire completed by patient)
number of injection received
Measured: Day 1 (questionnaire completed by patient)
Age of onset of sexual activity
Measured: Day 1 (questionnaire completed by patient)
Vaccine received
Measured: Day 1 (questionnaire completed by patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start4 Dec 2017
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Why it stopped: manager's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HPV VaccinationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328013
- Sponsor's protocol ID
- HPVAC (29BRC17.0086)
- Acronym
- HPVAC
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baudoin A, Sabiani L, Oundjian F, Tabouret E, Agostini A, Courbiere B, Boubli L, Carcopino X. [HPV prophylactic vaccine coverage and factors impacting its practice among students and high school students in Marseilles' area]. J Gynecol Obstet Biol Reprod (Paris). 2015 Feb;44(2):126-35. doi: 10.1016/j.jgyn.2014.02.005. Epub 2014 Apr 2. French.
PubMed 24703591Doris B, Boyer L, Lavoue V, Riou F, Henno S, Tas P, Sevene L, Leveque J. [Cervical Pap smear in an epidemiologically exposed population: ideas, facts and arguments]. J Gynecol Obstet Biol Reprod (Paris). 2014 Jan;43(1):26-34. doi: 10.1016/j.jgyn.2013.11.012. Epub 2013 Dec 12. French.
PubMed 24332738Carcopino X, Camus C, Halfon P. [Diagnosis and clinical management of cervical HPV infections]. Presse Med. 2015 Jul-Aug;44(7-8):716-26. doi: 10.1016/j.lpm.2015.02.020. Epub 2015 Jun 9. No abstract available. French.
PubMed 26067573Wafo E, Ivorra-Deleuze D, Thuillier C, Rouzier R. [Evolution of the awareness of Human Papillomavirus (HPV) in the French population: Results of a telephonic inquiry]. J Gynecol Obstet Biol Reprod (Paris). 2010 Jun;39(4):305-9. doi: 10.1016/j.jgyn.2010.03.007. Epub 2010 Apr 28. French.
PubMed 20430535Bouvret P, Mougin C, Pretet JL, Meurisse A, Bonnetain F, Fiteni F. [Practices and attitudes regarding HPV vaccination among general practitioners from Besancon]. J Gynecol Obstet Biol Reprod (Paris). 2016 Oct;45(8):972-978. doi: 10.1016/j.jgyn.2015.12.002. Epub 2016 Jan 15. French.
PubMed 26780841Riethmuller D, Ramanah R, Carcopino X, Leveque J. [The follow up of the women vaccinated against HPV]. J Gynecol Obstet Biol Reprod (Paris). 2013 Oct;42(6):525-33. doi: 10.1016/j.jgyn.2013.03.013. Epub 2013 May 10. French.
PubMed 23669416
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malvacdecision.Net
- ClinicalTrials.gov ID
- NCT03328013
- Acronym / sponsor ID
- HPVAC / HPVAC (29BRC17.0086)
- Conditions
- HPV Vaccination, Pap Smear, Cervical Cancer, Catch-up Vaccination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: manager's decision
- Enrolment
- 191 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 1 Nov 2017 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 33 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women, aged 25 to 33 in 2017, with a smear analyzed at the Brest University Hospital, vaccinated or not against HPV
Key inclusion criteria (3 listed)
- women
- aged 25 to 33 in 2017
- with a smear analyzed at the Brest University Hospital
Key exclusion criteria (3 listed)
- men
- age over 33 years or less than 25 years
- patient refusing to participate
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
Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status
Time frame: Day 1
4 secondary outcomes
age of occurrence of lesions according to the year of vaccination
Time frame: Day 1 (questionnaire completed by patient)
number of injection received
Time frame: Day 1 (questionnaire completed by patient)
Age of onset of sexual activity
Time frame: Day 1 (questionnaire completed by patient)
Vaccine received
Time frame: Day 1 (questionnaire completed by patient)
Results and safety
The study was stopped early (reason given: manager's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 24703591Baudoin A, Sabiani L, Oundjian F, Tabouret E, Agostini A, Courbiere B, Boubli L, Carcopino X. [HPV prophylactic vaccine coverage and factors impacting its practice among students and high school students in Marseilles' area]. J Gynecol Obstet Biol Reprod (Paris). 2015 Feb;44(2):126-35. doi: 10.1016/j.jgyn.2014.02.005. Epub 2014 Apr 2. French.
- Background: PubMed 24332738Doris B, Boyer L, Lavoue V, Riou F, Henno S, Tas P, Sevene L, Leveque J. [Cervical Pap smear in an epidemiologically exposed population: ideas, facts and arguments]. J Gynecol Obstet Biol Reprod (Paris). 2014 Jan;43(1):26-34. doi: 10.1016/j.jgyn.2013.11.012. Epub 2013 Dec 12. French.
- Background: PubMed 26067573Carcopino X, Camus C, Halfon P. [Diagnosis and clinical management of cervical HPV infections]. Presse Med. 2015 Jul-Aug;44(7-8):716-26. doi: 10.1016/j.lpm.2015.02.020. Epub 2015 Jun 9. No abstract available. French.
- Background: PubMed 20430535Wafo E, Ivorra-Deleuze D, Thuillier C, Rouzier R. [Evolution of the awareness of Human Papillomavirus (HPV) in the French population: Results of a telephonic inquiry]. J Gynecol Obstet Biol Reprod (Paris). 2010 Jun;39(4):305-9. doi: 10.1016/j.jgyn.2010.03.007. Epub 2010 Apr 28. French.
- Background: PubMed 26780841Bouvret P, Mougin C, Pretet JL, Meurisse A, Bonnetain F, Fiteni F. [Practices and attitudes regarding HPV vaccination among general practitioners from Besancon]. J Gynecol Obstet Biol Reprod (Paris). 2016 Oct;45(8):972-978. doi: 10.1016/j.jgyn.2015.12.002. Epub 2016 Jan 15. French.
- Background: PubMed 23669416Riethmuller D, Ramanah R, Carcopino X, Leveque J. [The follow up of the women vaccinated against HPV]. J Gynecol Obstet Biol Reprod (Paris). 2013 Oct;42(6):525-33. doi: 10.1016/j.jgyn.2013.03.013. Epub 2013 May 10. French.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vaccination and Pap Smear, 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 26 Oct 2021. 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: manager's decision). 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?
Nature of smear: normal or not (including ASCUS and AGC) according to their immunization status (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328013, which also lists 6 linked publications.
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 26 Oct 2021.