Skip to main content
OpenTrials
Completed

NCT Number: NCT04939350

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

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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 An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

patients will complete a vaccination questionnaire

Primary outcomes

  1. percentage fully immunization coverage

    Time frame: Day 0

    percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample

Secondary outcomes

  1. percentage DTpolio immunization coverage

    Time frame: Day 0

    Percentage of vaccination against DTPolio

  2. percentage HAV immunization coverage

    Time frame: Day 0

    Percentage of vaccination against HAV

  3. percentage HBV immunization coverage

    Time frame: Day 0

    Percentages of vaccination against HBV

  4. percentage Pneumococcal immunization coverage

    Time frame: Day 0

    Percentages of vaccination against pneumococcaL

  5. percentage Influenza virus immunization coverage

    Time frame: Day 0

    Percentage of vaccination against seasonal influenza

  6. percentage COVID immunization coverage

    Time frame: Day 0

    Percentage of vaccination against COVID19

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study 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.

Acronym: VACCIR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.