Clinical trial NCT04180228: Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.
Official title: Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Idiopathic Juvenile Arthritis
Human Papilloma Virus
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 76
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of HPV vaccination (percentage of patients vaccinated).
timeFrame: Day 0, Time of intervention (questionnaire)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Paris
country: France
facility: Hôpital Necke -, Enfants Malades
city: Pierre-Bénite
country: France
facility: Service de médecine interne, Centre hospitalier Lyon Sud
Study officials:
References: