Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.

Systemic Lupus Erythematosus Clinical Trial

— HPV-CIR  

Official title:

Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180228
• Other study ID #: 69HCL19_0456
• Status: Completed
• Start date: January 23, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: December 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Collagen Diseases
• Human Papilloma Virus
• Idiopathic Juvenile Arthritis
• Lupus Erythematosus, Systemic
• Papilloma
• Rheumatic Diseases
• Systemic Lupus Erythematosus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron
France	Hôpital Necke -, Enfants Malades	Paris
France	Service de médecine interne, Centre hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)