Clinical Trials Logo
  1. Home
  2. Cirrhosis, Liver
  3. NCT05028322

Evaluation of Intradermal Hepatitis B Vaccine After IMIQUIMOD's Application, in Cirrhotics Who Did Not Respond to the Usual Vaccine Regimen — IDMODVHB  

Cirrhosis, Liver Clinical Trial

Official title:
Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination After Topical Application of IMIQUIMOD, in Cirrhotics Patients, Who Did Not Respond to the Conventional Vaccine Regimen: a Pilot Study

Clinical Trial Summary

In a population of cirrhotics patients who did not responde to an anti-HBV vaccination according to the recommended vaccination, the goal is to : Describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0-M1-M6 vaccine regimen using 3 vaccines strategies : - After simple intramuscular vaccine (IM) ( Control group ) - After simple intradermal vaccine - after IMIQUIMOD's application followed by intradermal vaccine administration The main hypothesis of this study is : IMIQUIMOD acts as an immunity booster, so the combination of IMIQUIMOD with an intra-dermal injection of the anti-HBV vaccine allows better acquisition of post-vaccination immunization.

Clinical Trial Description

This study will be in a population of Cirrhotic patients who have already received a HBV vaccination with a conventional regimen and who have not responded (characterized by a level of antibody Hbs < 10UI/ml at the end of the vaccine regimen). In current recommendations, up to 3 additional injections of HBV vaccine should be injected to obtain an antibody level> 10 mIU / ml. In this study, the investigator will describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0-M1-M6 vaccine regimen using 3 vaccines strategies : - After simple intramuscular vaccine (IM) ( Control group ) - After simple intradermal vaccine - after IMIQUIMOD's application followed by intradermal vaccine administration ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05028322
Study type Interventional
Source Central Hospital, Nancy, France
Contact
Status Not yet recruiting
Phase Phase 2
Start date November 1, 2021
Completion date December 1, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05793983 - S100A8/A9 and Innate Immunity in Liver Disease
Completed NCT04604860 - Use of EL-FIT App to Promote Physical Activity N/A
Recruiting NCT05928624 - A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients N/A
Active, not recruiting NCT01438970 - Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function Phase 2
Recruiting NCT05998330 - LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease N/A
Completed NCT04581369 - Cirrhosis Medical Home N/A
Withdrawn NCT04244877 - Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility Phase 3
Recruiting NCT04588077 - Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis Phase 4
Recruiting NCT05538962 - Longitudinal Monitoring of Inflammation in Cirrhosis N/A
Completed NCT04082780 - Rifamycin in Minimal Hepatic Encephalopathy Phase 2
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Active, not recruiting NCT03736265 - Carvedilol for Prevention of Esophageal Varices Progression N/A
Recruiting NCT04530760 - Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Recruiting NCT05093218 - Effect of Branch Chain Amino Acid Therapy on Sarcopenia in Children With Chronic Liver Disease. N/A
Recruiting NCT03437876 - Study on Effect of Intestinal Microbiota Transplantation in Hepatitis B Virus Induced Cirrhosis N/A
Recruiting NCT05604274 - Longitudinal Monitoring of Stool Characteristics
Recruiting NCT04867954 - Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
Completed NCT04643795 - Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects Phase 1
Active, not recruiting NCT02344680 - Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Completed NCT04121520 - Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey