Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.

NCT ID: NCT04180228

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-23

Study Completion Date

2021-05-04

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus Idiopathic Juvenile Arthritis Human Papilloma Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

self-administred questionnaire

Intervention Type OTHER

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.

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.

self-administred questionnaire

Intervention Type OTHER

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.

Interventions

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self-administred questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Refusing to participate
* Age \< 11 years old
Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Femme Mère Enfant

Bron, , France

Site Status

Hôpital Necke -, Enfants Malades

Paris, , France

Site Status

Service de médecine interne, Centre hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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69HCL19_0456

Identifier Type: -

Identifier Source: org_study_id