HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi - LARVOL DELTA

Management of non-response to Hepatitis B re-vaccination. (PubMed, Occup Med (Lond)) - "Our results demonstrate the rationale for offering additional vaccination with Fendrix® to HCWs when standard vaccination and repeated administration has not elicited an adequate immune response. Multi-centre evaluation of this vaccination strategy for non-responder HCWs should be considered to generate evidence for the most acceptable and efficacious approach."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Establishment of a Hep B vaccination programme. (UKKW 2024) - "Hep B vaccination Responders (HBvaxPRO, Fendrix, Engerix) : The establishment of the Hepatitis B vaccination programme has been a success with an increasing number of patients achieving immunity. During the process we have developed a patient centred service that sits alongside our existing kidney care team."

Chronic Kidney Disease • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

Efficacy of Hepatitis B Virus Vaccines HBVaxpro40© and Fendrix© in Patients with Chronic Liver Disease in Clinical Practice. (PubMed, Vaccines (Basel)) - "In the univariate analysis, active alcohol intake, alcohol etiology, liver cirrhosis and ultrasound signs of portal hypertension were associated with a lower response to vaccination, whereas in the multivariate analysis, liver cirrhosis was the only factor that significantly increased the likelihood of nonresponse (OR 10.5). HBVAXPRO and FENDRIX are good options for HBV vaccination in patients with chronic liver disease."

Journal • Cardiovascular • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Hypertension • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Portal Hypertension

Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease. (clinicaltrials.gov) - P=N/A | N=125 | Completed | Sponsor: Corporacion Parc Tauli | Unknown status ➔ Completed | N=200 ➔ 125 | Trial completion date: Apr 2020 ➔ Aug 2021 | Trial primary completion date: Apr 2019 ➔ Aug 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Cholecalciferol supplementation to improve the hepatitis B vaccination response in hemodialysis patients: A first randomized open label pilot study (DeVitaHep). (PubMed, Vaccine) - P3 | "In this small pilot study, high-dose oral cholecalciferol supplementation did not improve the hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency. This clinical trial was registered within EudraCT (EudraCT number 2011-004621-26)."

Clinical • Journal • Chronic Kidney Disease • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

EFFECTIVENESS OF THE HBVAXPRO® AND FENDRIX® HEPATITIS B VACCINES IN CHRONIC LIVER DISEASE IN CLINICAL PRACTICE (AEEH 2021) - No abstract available

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

[VIRTUAL] Efficacy of hepatitis B virus vaccines HBVaxpro40 and Fendrix in patients with chronic liver disease in clinical practice (EASL-ILC 2021) - "103 patients were included (mean age 62.4 years; 56.3% males; 36.9 liver cirrhosis, 89.5% of whom were Child A). The aetiology of chronic liver disease was 33% alcohol, 27.2% metabolic, 23.3% virus c hepatitis and 16.5% autoimmune/primary biliary cholangitis. 73 patients were vaccinated with HBVaxpro40 and 30 with Fendrix."

Clinical • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Hypertension • Infectious Disease • Inflammation • Liver Cirrhosis • Portal Hypertension • Primary Biliary Cholangitis

Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders: double-blinded, randomised, controlled phase 2 trial. (PubMed, Liver Int) - "In this group of hepatitis B vaccine non-responders, the HBAI20 vaccine demonstrated a higher seroprotection rate when adjusting for stratification factors and a similar safety profile compared to the licensed recombinant HBVaxPro®-10µg."

Clinical • Journal • P2 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • IL2

Efficacy of an accelerated double dose Hepatitis B vaccine regimen in patients with cirrhosis. (PubMed, J Viral Hepat) - "All patients with cirrhosis admitted to the hepatology ward without exclusion criteria were offered the HBV HBVAXPRO 40mcg vaccine at months 0, 1 and 2...Only one patient had a mild adverse event.Most patients with cirrhosis admitted in the Hepatology ward are unprotected against HBV. Although a second HBV vaccination cycle increases the response rate, the poor overall response reinforces the implementation of HBV vaccination before the development of cirrhosis."

Clinical • Journal • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Transplantation

A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) (clinicaltrials.gov) - P3; N=207; Completed; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Hepatitis B • Hepatology • Infectious Disease

A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) (clinicaltrials.gov) - P3; N=200; Active, not recruiting; Sponsor: Merck Sharp & Dohme Corp.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hepatitis B • Hepatology • Infectious Disease

A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatitis B • Hepatology • Infectious Disease

[VIRTUAL] Response to a double dose (40 mcg) and an accelerated schedule (0-1-2 months) of hepatitis B vaccine in patients with advance cirrhosis. A prospective study (EASL-ILC-I 2020) - "The first dose of the HBVAXPRO 40mcg vaccine was administered during admission, and at month 1 and 2 in the Preventive Medicine Unit... This is the biggest prospective study evaluating HBV vaccination response in cirrhotic patients. More than 80% of patients with advanced cirrhosis admitted to a referral hepatology unit were unprotected against HBV. The response to a double dose and accelerated cycle of HBV vaccine was low (22%), but it improved significantly (61%) after a second cycle."

Clinical • Diabetes • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatitis C Virus • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Metabolic Disorders • Non-alcoholic Steatohepatitis • Oncology • Preventive care • Solid Tumor • Transplantation