Fendrix (hepatitis B (rDNA) vaccine adjuvanted, adsorbed) / GSK - 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

Optimizing hepatitis B vaccination in chronic kidney disease: a comprehensive scoping review of strategies across CKD stages, dialysis, and transplant populations. (PubMed, Ren Fail) - "Accordingly, 4 times of either double-dose simple recombinant vaccine (Engerix-B 40 mcg) or adjuvanted vaccines (e.g., Fendrix®, Heplisav-B® 20 mcg) demonstrated higher seroprotection rates than the standard conventional schedule (3 times of Engerix-B 20 mcg). In conclusion, the higher doses of vaccination are required in adult patients with CKD; however, data on transplant recipients and pediatric patients are very limited. Large-scale, high-quality randomized controlled trials with long-term immunity monitoring are needed."

Journal • Review • Chronic Kidney Disease • Hepatitis B • Infectious Disease • Inflammation • Nephrology • Pediatrics • Renal Disease • Transplantation

Immunogenicity and predictive factors of hepatitis B vaccination with Fendrix® in chronic kidney disease patients. (PubMed, Front Public Health) - "The decline in antibody levels suggests the need for booster doses and periodic antibody monitoring to optimize long-term protection. Suboptimal vaccination adherence may reflect the inherent complexities of real-world clinical practice."

Biomarker • Journal • Retrospective data • Chronic Kidney Disease • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (clinicaltrials.gov) - P1/2 | N=122 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed | Phase classification: P1 ➔ P1/2

Phase classification • Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (clinicaltrials.gov) - P1 | N=122 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2024 ➔ Dec 2024

Combination therapy • Enrollment closed • Trial primary completion date • Hepatitis B • Hepatology • 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

A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: GlaxoSmithKline | Phase classification: P1/2 ➔ P1 | Trial completion date: Aug 2024 ➔ Jan 2025 | Trial primary completion date: Oct 2023 ➔ Mar 2024

Combination therapy • Phase classification • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Effectiveness of the hepatitis B vaccine adjuvanted with AS04C in patients with biological therapies. (PubMed, Vaccine) - "The hepatitis B vaccine adjuvanted with AS04C (Fendrix®) produces an adequate immune response in patients with autoimmune diseases and immunosuppressive and/or immunomodulating therapies. This immunization schedule is proposed as a very suitable and adapted option for the protection of patients with autoimmune diseases under active biological therapies."

Journal • Hepatitis B • Hepatology • Immune Modulation • Immunology • Infectious Disease • Inflammation

A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Immunogenicity and safety of a booster dose of the hepatitis B vaccine HepB-CpG (HEPLISAV-B®) compared with HepB-Eng (Engerix-B®) and HepB-AS04 (Fendrix®) in adults receiving hemodialysis who previously received hepatitis B vaccination and are not seroprotected: Results of a randomized, multicenter phase 3 study. (PubMed, Hum Vaccin Immunother) - "In this difficult-to-immunize population, a booster dose of HepB-CpG induced significantly higher levels of seroprotection than HepB-Eng with a similar safety profile. The higher levels of immunogenicity were not accompanied by higher levels of local post-injection reactions compared with HepB-AS04."

Journal • P3 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (clinicaltrials.gov) - P1/2 | N=150 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1/2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A comparison of two Fendrix hepatitis B vaccination schedules in patients with inflammatory bowel disease. (PubMed, Vaccine) - "One-third of patients obtained seroprotection after only one double dose vaccine. A double dose may be considered in patients with IBD at high short-term risk of HBV infection when a rapid protective response is warranted."

Journal • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease

A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses (clinicaltrials.gov) - P2/3 | N=13 | Completed | Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust | Active, not recruiting ➔ Completed | N=30 ➔ 13 | Trial completion date: Dec 2022 ➔ Jun 2022 | Trial primary completion date: Dec 2022 ➔ Jun 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

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