Vaccination for liver transplant candidates
VACcination of LIver Transplantation Candidates: Efficacy, Tolerance and Acceptability Prospective Cohort Study.
This study tests if getting vaccinated can help people waiting for a liver transplant stay healthier and avoid serious infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | rituximab, chemotherapy, prednisone |
| Locations | 1 site (Lyon) |
| Trial ID | NCT04446832 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients awaiting liver transplantation, who are at increased risk for severe infections due to their compromised immune systems. It aims to evaluate the immunogenicity of vaccines in these patients, ensuring they receive appropriate vaccinations to prevent infections that could complicate their condition. The study involves candidates referred by the hepato-gastroenterology department for pre-transplant evaluation and assesses their vaccination status and response. By updating vaccinations, the study seeks to improve the overall health and safety of liver transplant candidates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are awaiting liver transplantation and have been referred for pre-transplant evaluation.
Not a fit: Patients who are candidates for multi-organ transplants or those who have received significant immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the immune response to vaccinations in liver transplant candidates, reducing their risk of severe infections.
How similar studies have performed: Other studies have indicated the importance of vaccination in immunocompromised populations, suggesting that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥ 18 years old * patients waiting for liver transplantation referred by hepato-gastroenterology department as part of the pre-transplant evaluation to the infectiology consultation * patient who were informed of the study and did not object to participate Exclusion Criteria: * patient candidate for multi-organ transplant * patient who received immunosuppressive therapy, biotherapy and/ or corticosteroid therapy at a dose greater than 10 mg / day of prednisone equivalent for more than 2 weeks within 3 months before vaccination (6 months of rituximab) * patient who received polyvalent immunoglobulins within the 6 months before the serological evaluation * patient who received systemic anti-cancer chemotherapy for solid tumor or hemopathy within 6 months preceding the start of vaccination * splenectomized patients * asplenic patients for a reason other than liver disease * chronic infection with the human immunodeficiency virus (HIV) * patient with any other hereditary immune deficiency or acquired which could compromise the vaccine response or interpretation of serological results * patient under legal protection measure or unable to consent to the study
Where this trial is running
Lyon
- Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Florent VALOUR, Dr
- Email: florent.valour@chu-lyon.fr
- Phone: 04 72 07 11 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.