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

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

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

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: 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 An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the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 Type: Observational
• Enrollment (Actual): 742

Contacts and Locations

Study Locations

• France
  • France
    • Corbeil-Essonnes, France, France, 91106
      • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All cirrhotic patients followed for at least 6 months in consultation or hospitalization during the duration of the study in the general hospitals members of the ANGH participating in the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage DTpolio immunization coverage	Percentage of vaccination against DTPolio	Day 0
percentage HAV immunization coverage	Percentage of vaccination against HAV	Day 0
percentage HBV immunization coverage	Percentages of vaccination against HBV	Day 0
percentage Pneumococcal immunization coverage	Percentages of vaccination against pneumococcaL	Day 0
percentage Influenza virus immunization coverage	Percentage of vaccination against seasonal influenza	Day 0
percentage COVID immunization coverage	Percentage of vaccination against COVID19	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): December 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: COVID; cirrhosis; poliomyelitis; vaccination; tetanus; hepatitis B; hepatitis A; cirrhotic; pneumococcus; Vaccinal coverage; influenzae virus
• Additional Relevant MeSH Terms: Blood-Borne Infections; Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Spinal Cord Diseases; Hepadnaviridae Infections; Central Nervous System Infections; Hepatitis; Myelitis; Clostridium Infections; Pathological Conditions, Signs and Symptoms; Hepatitis A; Fibrosis; Hepatitis B; Poliomyelitis; Tetanus; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2021-A00343-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No