Clinical trial NCT03653377: Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)
Official title: Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucoviscidosis
Keywords: mucoviscidosis
Human Papilloma Virus
Vaccination
Young girl
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 81
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of minor girls with cystic fibrosis older than 9 years, followed in a pediatric Mucoviscidosis Resource and Competence Center (MRCC).

Brief summary: Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.

Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

The secondary objectives are to know:

* The type of vaccine used (bivalent / quadrivalent / nonavalent)
* The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
* Reasons for non-use of vaccination

Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.

Population

* young girls aged 9 years or older with Cystic fibrosis
* Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
* With parents who did not object to participation in the study

Number of subject: 62 patients

Expected results

* Knowledge of HPV vaccination coverage in young girls with CF.
* Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.


Eligibility criteria: Inclusion Criteria:

* young girls aged 9 years or older
* patients with Cystic Fibrosis
* patients followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
* patients with parents who did not object to participation in the study

Exclusion Criteria:

-patients who refuse to answer to the self-administrated questionnaire

Primary outcomes:
measure: HPV vaccination
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service Mucoviscidose, Pneumologie
city: Clermont-Ferrand
country: France
facility: Hôpital d'Estaing
city: Grenoble
country: France
facility: Pôle Couple / Enfant
city: Paris
country: France
facility: CRCM, Hôpital Robert Debré
city: Paris
country: France
facility: CRCM, Hôpital Trousseau
city: Paris
country: France
facility: CRCM, Institut Necker Enfants Malade
city: Pierre-Bénite
country: France
facility: Centre de Ressources et de Compétences de la Mucoviscidose Adultes
Study officials:
affiliation: Hospices Civils de Lyon
name: Christine ROUSSET-JABLONSKI, MD
role: PRINCIPAL_INVESTIGATOR
References: