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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04939350
Acronym
VACCIR
Enrollment
742
Registered
2021-06-25
Start date
2021-09-27
Completion date
2022-12-27
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Keywords

Vaccinal coverage, vaccination, cirrhosis, cirrhotic, COVID, hepatitis B, hepatitis A, influenzae virus, pneumococcus, tetanus, poliomyelitis

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

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

Interventions

OTHERquestionnaire

patients will complete a vaccination questionnaire

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
percentage fully immunization coverageDay 0percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample

Secondary

MeasureTime frameDescription
percentage DTpolio immunization coverageDay 0Percentage of vaccination against DTPolio
percentage HAV immunization coverageDay 0Percentage of vaccination against HAV
percentage HBV immunization coverageDay 0Percentages of vaccination against HBV
percentage Pneumococcal immunization coverageDay 0Percentages of vaccination against pneumococcaL
percentage Influenza virus immunization coverageDay 0Percentage of vaccination against seasonal influenza
percentage COVID immunization coverageDay 0Percentage of vaccination against COVID19

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026