VACCIR: Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021

Sponsor

Centre Hospitalier Sud Francilien (Other)

Overall Status

Recruiting

CT.gov ID

NCT04939350

Collaborator

(none)

1,000

Enrollment

Location

9.1

Anticipated Duration (Months)

110.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis	Other: questionnaire

Detailed Description

Cirrhosis is a serious liver disease very common in France, affecting nearly 200,000 people. These patients have an impaired immune response. They are, therefore, more frequently prone to bacterial, viral and fungal infections and these are more severe with high mortality. 30-50% of cirrhotics admitted to a hospital ward have sepsis, with pneumococcal bacterial infections being particularly severe. The risk of developing seasonal influenza is 5.7 times higher in cirrhotics with a risk of mortality multiplied by 169. COVID19 infection is responsible for a very high mortality (34%) in case of severe resuscitation form. Acute infections with hepatitis A (HAV) and B (HBV) viruses frequently lead to worsening liver failure decompensating to cirrhosis, and sometimes life-threatening fulminant hepatitis. Finally, chronic infection with the hepatitis B virus combined with another etiology of cirrhosis accelerates the course of liver disease and promotes the occurrence of hepatocellular carcinoma.

Limiting the incidence of viral and bacterial infections in these patients is crucial. The High Authority of Health (HAS) published recommendations in 2007 advising patients with cirrhosis vaccinations against hepatitis A and B viruses, influenza and against bacterial pneumococcal infections, confirmed by the High Council of Public Health.

There are few data on vaccination coverage among cirrhotic patients. An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the hepatitis A virus. No recent studies have assessed the impact of the HAS recommendations.

The purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of the Vaccination Coverage in a Prospective Cohort of Cirrhotic Patients Followed in the General Hospitals in France in 2021 and in 2022.

Actual Study Start Date :

Sep 27, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Outcome Measures

Primary Outcome Measures

percentage fully immunization coverage [Day 0]
percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample

Secondary Outcome Measures

percentage DTpolio immunization coverage [Day 0]
Percentage of vaccination against DTPolio
percentage HAV immunization coverage [Day 0]
Percentage of vaccination against HAV
percentage HBV immunization coverage [Day 0]
Percentages of vaccination against HBV
percentage Pneumococcal immunization coverage [Day 0]
Percentages of vaccination against pneumococcaL
percentage Influenza virus immunization coverage [Day 0]
Percentage of vaccination against seasonal influenza
percentage COVID immunization coverage [Day 0]
Percentage of vaccination against COVID19

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

adult patient
histologically proven or asserted cirrhosis on a combination of clinical, biological, endoscopic and radiological criteria
follow-up of cirrhosis > 6 months
subject informed of the study and not having objected to it.

Exclusion Criteria:

immunosuppression not related to liver disease: HIV, variable common immune deficiency, chemotherapy, anatomical splenectomy, immunosuppressive treatments for non-hepatic disease
vaccine contraindication.