Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.

NCT04180228 | Completed

• 1 other identifier: 69HCL19_0456
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 3

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.

Conditions

Systemic Lupus Erythematosus; Idiopathic Juvenile Arthritis; Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0, Time of intervention (questionnaire)

Study Arms (2)

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.

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.

Other: self-administred questionnaire

Interventions

self-administred questionnaire 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; Systemic lupus erythematosus

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Refusing to participate
• Age \< 11 years old

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

Hôpital Necke -, Enfants Malades

Paris, 75743, France

Location

Service de médecine interne, Centre hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 27, 2019
• Study Start: January 23, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

FR (3)