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

Cirrhosis Clinical Trial

— VACCIR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939350
• Other study ID #: IDRCB 2021-A00343-38
• Status: Completed
• Start date: September 27, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

Other:
• questionnaire
patients will complete a vaccination questionnaire

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage fully immunization coverage	percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample	Day 0
Secondary	percentage DTpolio immunization coverage	Percentage of vaccination against DTPolio	Day 0
Secondary	percentage HAV immunization coverage	Percentage of vaccination against HAV	Day 0
Secondary	percentage HBV immunization coverage	Percentages of vaccination against HBV	Day 0
Secondary	percentage Pneumococcal immunization coverage	Percentages of vaccination against pneumococcaL	Day 0
Secondary	percentage Influenza virus immunization coverage	Percentage of vaccination against seasonal influenza	Day 0
Secondary	percentage COVID immunization coverage	Percentage of vaccination against COVID19	Day 0