Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases. (HPV-CIR)

December 9, 2021 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hopital Femme Mere Enfant
      • Paris, France, 75743
        • Hôpital Necke -, Enfants Malades
      • Pierre-Bénite, France, 69310
        • Service de médecine interne, Centre hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of HPV vaccination (percentage of patients vaccinated).
Time Frame: 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.
Day 0, Time of intervention (questionnaire)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2020

Primary Completion (Actual)

May 4, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0456

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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