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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180228
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Idiopathic Juvenile Arthritis Human Papilloma Virus Other: self-administred questionnaire

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180228


Contacts
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Contact: Emmanuelle DAVID 6 74 39 72 50 ext +33 emmanuelle.david01@chu-lyon.fr
Contact: Christine ROUSSET-JABLONSKI, MD 4 78 56 90 49 ext +33 christine.rousset-jablonski@chu-lyon.fr

Locations
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France
Hôpital Femme Mère Enfant Recruiting
Bron, France, 69677
Contact: Alexandre BELOT, MD         
Principal Investigator: Alexandre BELOT, MD         
Hôpital Robert Debré, AP-HP Recruiting
Paris, France, 75019
Contact: Ulrich MEINZER, MD         
Principal Investigator: Ulrich MEINZER, MD         
Hôpital Necke -, Enfants Malades Recruiting
Paris, France, 75743
Contact: Brigitte BADER-MEUNIER, MD         
Principal Investigator: Brigitte BADRE-MEUNIER, MD         
Service de médecine interne, Centre hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Contact: Emmanuelle DAVID    6 74 39 72 50 ext +33    emmanuelle.david01@chu-lyon.fr   
Contact: Christine ROUSSET-JABLONSKI, MD    4 78 56 90 49 ext +33    christine.rousset-jablonski@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04180228    
Other Study ID Numbers: 69HCL19_0456
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Papilloma
Rheumatic Diseases
Arthritis, Juvenile
Lupus Erythematosus, Systemic
Collagen Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms