HPV Vaccination in Women With Cystic Fibrosis

Human Papillomavirus Infection Clinical Trial

— VACCIN-HPV-MUC  

Official title:

HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265743
• Other study ID #: 69HCL17_0277
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: February 14, 2018
• Start date: September 25, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main risk factor for the development of cervical lesions is human papillomavirus (HPV) infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to 14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical pathology. Despite this, human papillomavirus vaccination coverage remains low in France.

Some women with cystic fibrosis might need a transplantation, which is a factor associated with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of cervical pathology would also be present in non-transplanted women with cystic fibrosis. Particular attention should therefore be paid to vaccination in this population.

The objective is to estimate the frequency of human papillomavirus vaccination in young patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Gender: Female
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• girls with Cystic Fibrosis

• followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA)

• aged 11 years or older

Exclusion Criteria:

• Refusal to respond to the questionnaire

Related Conditions & MeSH terms

• Cystic Fibrosis
• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Other:
• Self-report Written Questionnaire
Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.

Locations

Country	Name	City	State
France	Nouvel Hôpital d'Estaing CRCM Mixte	Clermont-Ferrand
France	CHU Grenoble	Grenoble
France	Cystic Fibrosis Reference Center, Hospices Civils de Lyon	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	Realization of human papillomavirus vaccination	The main outcome is the prevalence of human papillomavirus vaccination in young women with Cystic fibrosis.; This data is collected using a questionnaire : HPV vaccination performed : yes/no	15 minutes
Secondary	Type of vaccine used	This data is collected using a questionnaire : bivalent (Cervarix®) or quadrivalent (Gardasil®)	15 minutes
Secondary	Respect for the vaccinal plan	This data is collected using a questionnaire : number and dates of injections	15 minutes
Secondary	Reasons for non-vaccination	In case of non-vaccination reasons are collected using a multiple choices questionnaire	15 minutes