Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.

Completed

• Conditions: Systemic Lupus Erythematosus; Idiopathic Juvenile Arthritis; Human Papilloma Virus
• Interventions: Other: self-administred questionnaire

• Registration Number: NCT04180228
• Lead Sponsor: Hospices Civils de Lyon

Brief 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. 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

Not available

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Study Start: 2020-01-23
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

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Exclusion Criteria

• Refusing to participate
• Age < 11 years old

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Systemic lupus erythematosus	self-administred questionnaire	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.
Idiopathic juvenile arthritis	self-administred questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Frequency of HPV vaccination (percentage of patients vaccinated).	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.

Trial Locations

Locations (3)

Service de médecine interne, Centre hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

Hôpital Necke -, Enfants Malades; 🇫🇷 Paris, France

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France