Systemic Lupus ErythematosusHPV-CIRNCT04180228
Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.
An observational study of Systemic Lupus Erythematosus and Idiopathic Juvenile Arthritis, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Patients with chronic inflammatory rheumatic disease (CIR) are at increased risk for infections. Vaccination is a powerful tool to prevent infections, even in immunocompromised patients. Read more about this study
- Who is it for?
- Ages 11 to 19 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Idiopathic Juvenile Arthritis, Human Papilloma Virus
- What is being tested?
- self-administred questionnaire
- Type of treatment
- Vaccines
- How many people
- 76 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Jan 2020to 4 May 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 11 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Investigators study a French sample of young girls follow-up for systemic lupus erythematosus or idiopathic juvenile arthritis. It's a multicenter design.
Who may be able to join
- Young girls older than 11 years old until adult transition
- Follow-up for systemic lupus erythematosus (American college of rheumatology classification) or idiopathic juvenile arthritis (International League of Associations for Rheumatology classification)
- Follow-up in a Childen's hospital of Lyon (Hopital Femme Mère Enfant) and Paris (Hospital Necker-Enfants Malades, Hôpital Robert Debré)
- With no parental opposition to participate
Who cannot join
- Refusing to participate
- Age < 11 years old
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Femme Mère Enfant
Bron, 69677
Hôpital Necke -, Enfants Malades
Paris, 75743
Service de médecine interne, Centre hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
Official title: Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.
Patients with chronic inflammatory rheumatic disease (CIR) are at increased risk for infections. Vaccination is a powerful tool to prevent infections, even in immunocompromised patients. Low-risk types of Human papilloma virus (HPV) cause anogenital warts, while high risk types are strongly related to pre-malignant cervical abnormalities and cervical cancer. HPV vaccines have been developed to prevent these conditions. Human papillomavirus (HPV) infections are more prevalent in systemic lupus erythematosus (SLE) patients or other auto-immune diseases when compared to the healthy population. In France, despite a vaccination available since 2007, rate of vaccination remain low. Although little is known about HPV vaccination in SLE, few studies in patients with autoimmune rheumatic diseases (AIRDs) have shown that HPV vaccines are safe, and capable to induce an immunogenic response in this group of patients. To date, available data suggest that HPV vaccines can be given safely to SLE patients. Given the increased incidence of cervical abnormalities due to HPV in SLE patients, this vaccination should be encouraged.
The aim of this study was to assess the vaccination coverage rate in chronically ill girls with SLE or idiopathic juvenile arthritis who require a close pediatric specialized follow-up vaccination and to understand barriers or motivations for it.
- Being tested
- self-administred questionnaire
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administred questionnaireOther
On the occasion of a follow-up consultation with referent pediatrician, a self-administred questionnaire is distributed. It will take around ten minutes to the patient and her parents for completing the questionnaire. Questionnaire is anonymous. Participation is free and informed by an information notice. There is a list of items to complete by the patient and her parents. Most of questions are closed-ended. Clinical data are reported : age, level of education, principal disease (SLE or Juvenile arthritis), received treatments. In the questionnaire, it is asked if the patient is vaccinated or not for HPV, and reasons for it.
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus | Investigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire with systemic lupus erythematosus. Receives: Other: self-administred questionnaire | |
| Idiopathic juvenile arthritis | Investigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire, with idiopathic juvenile arthritis. Receives: Other: self-administred questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of HPV vaccination (percentage of patients vaccinated).
We report this information with an item "vaccination for Human papilloma virus". The proposition of response is "Yes" or "No". We'll calculate the number of vaccination among the population including in the study.
Measured: Day 0, Time of intervention (questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start23 Jan 2020
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180228
- Sponsor's protocol ID
- 69HCL19_0456
- Acronym
- HPV-CIR
- Status last verified
- Dec 2021
- First submitted
- 31 Oct 2019
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.
- ClinicalTrials.gov ID
- NCT04180228
- Acronym / sponsor ID
- HPV-CIR / 69HCL19_0456
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 27 Nov 2019 (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.
Patients with chronic inflammatory rheumatic disease (CIR) are at increased risk for infections. Vaccination is a powerful tool to prevent infections, even in immunocompromised patients. Low-risk types of Human papilloma virus (HPV) cause anogenital warts, while high risk types are strongly related to pre-malignant cervical abnormalities and cervical cancer. HPV vaccines have been developed to prevent these conditions. Human papillomavirus (HPV) infections are more prevalent in systemic lupus erythematosus (SLE) patients or other auto-immune diseases when compared to the healthy population. In France, despite a vaccination available since 2007, rate of vaccination remain low. Although little is known about HPV vaccination in SLE, few studies in patients with autoimmune rheumatic diseases (AIRDs) have shown that HPV vaccines are safe, and capable to induce an immunogenic response in this group of patients. To date, available data suggest that HPV vaccines can be given safely to SLE patients. Given the increased incidence of cervical abnormalities due to HPV in SLE patients, this vaccination should be encouraged.
The aim of this study was to assess the vaccination coverage rate in chronically ill girls with SLE or idiopathic juvenile arthritis who require a close pediatric specialized follow-up vaccination and to understand barriers or motivations for it.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus | – | Other: self-administred questionnaireInvestigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire with systemic lupus erythematosus. |
| Idiopathic juvenile arthritis | – | Other: self-administred questionnaireInvestigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire, with idiopathic juvenile arthritis. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Investigators study a French sample of young girls follow-up for systemic lupus erythematosus or idiopathic juvenile arthritis. It's a multicenter design.
Key inclusion criteria (4 listed)
- Young girls older than 11 years old until adult transition
- Follow-up for systemic lupus erythematosus (American college of rheumatology classification) or idiopathic juvenile arthritis (International League of Associations for Rheumatology classification)
- Follow-up in a Childen's hospital of Lyon (Hopital Femme Mère Enfant) and Paris (Hospital Necker-Enfants Malades, Hôpital Robert Debré)
- With no parental opposition to participate
Key exclusion criteria (2 listed)
- Refusing to participate
- Age < 11 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administred questionnaireOn the occasion of a follow-up consultation with referent pediatrician, a self-administred questionnaire is distributed. It will take around ten minutes to the patient and her parents for completing the questionnaire. Questionnaire is anonymous. Participation is free and informed by an information notice. There is a list of items to complete by the patient and her parents. Most of questions are closed-ended. Clinical data are reported : age, level of education, principal disease (SLE or Juvenile arthritis), received treatments. In the questionnaire, it is asked if the patient is vaccinated or not for HPV, and reasons for it. | Other | Idiopathic juvenile arthritis, Systemic lupus erythematosus |
Primary outcome
Frequency of HPV vaccination (percentage of patients vaccinated).
Time frame: Day 0, Time of intervention (questionnaire)
We report this information with an item "vaccination for Human papilloma virus". The proposition of response is "Yes" or "No". We'll calculate the number of vaccination among the population including in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Idiopathic Juvenile Arthritis, run by Hospices Civils de Lyon at 3 sites 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of HPV vaccination (percentage of patients vaccinated). (time frame: Day 0, Time of intervention (questionnaire)). 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 10 Dec 2021.