Engerix-B (hepatitis B vaccine recombinant) / GSK - LARVOL DELTA

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (clinicaltrials.gov) - P1/2 | N=290 | Completed | Sponsor: Baylor College of Medicine | Trial completion date: Sep 2025 ➔ Nov 2024 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Infectious Disease

Serological response to Engerix®-B vaccination in PLWHIV (EACS 2025) - "Conclusions : Standard Engerix®-B schedules led to moderate serological response among PLWHIV, with higher response rates in younger individuals. In our cohort, alternative strategies may be needed and a 3-dose course should be considered upfront for those with isolated anti-HBc."

Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • CD4

A NOVEL MRNA-BASED IMMUNOTHERAPY ACHIEVES COMPLETE ELIMINATION OF HUMAN HEPATITIS B VIRUS IN CHRONIC HBV MOUSE MODELS (AASLD 2025) - " We developed two mRNA-based immunomodulators (IMs) and evaluated their therapeutic potential in combination with entecavir and either a siRNA (Elebsiran) or an ASO (Bepirovirsen) in two distinct chronic HBV mouse models for elimination of HBV both in the periphery and intrahepatic compartment. Combination therapies containing one of the IMs led to a rapid and profound decline in HBsAg and HBV DNA, whereas prophylactic HBV vaccine (Engerix) had minimum impact on these viral markers... Our study demonstrated that either novel IMs, when used in combination with direct antivirals, achieved a rapid, robust, and sustained suppression of HBV infection in chronic mouse models. We observed rapid and sustained declines in HBsAg and HBV DNA in plasma and HBcAg in the liver. Unlike treatments lacking the IMs, which only induced a rapid yet transient HBsAg and HBV DNA decline followed by a rapid rebound of these viral markers once the treatments were discontinued, our approach..."

IO biomarker • Preclinical • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

HBV003: A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: Vaxine Pty Ltd | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Hepatitis B • Infectious Disease • Inflammation

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

Revaccination Response and Lack of Hepatitis B Reactivation After HCT for Sickle Cell Disease. (PubMed, Transpl Infect Dis) - "Results indicate that HBV immunity can decline post-HCT, but most patients remain immune, and revaccination is effective. However, some non-responders-especially those treated with IVIG, rituximab, or prolonged immunosuppression-need further study. Prospective research is needed to optimize revaccination timing and immune monitoring in this high-risk group."

Journal • Genetic Disorders • Hematological Disorders • Hepatitis B • Infectious Disease • Inflammation • Sickle Cell Disease • Transplantation

COMBAT-HBV: The COMBAT HBV Feasibility Trial (clinicaltrials.gov) - P4 | N=317 | Active, not recruiting | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Active, not recruiting | N=560 ➔ 317 | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2025

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

Description of Multicopy Recombinant Hepatitis B Surface Antigen: From Expression to Immune Analysis. (PubMed, Mol Biotechnol) - "The antigenic properties of the produced HBsAg were compared with those of the commercially available vaccine, Engerix B™. Immunological testing using serum from anti-HBsAg positive individuals and immunized animals demonstrated that the recombinant rHBsAg exhibited similar antigenic characteristics to the commercial vaccine. The findings of this study indicate that the recombinant HBsAg exhibits immunological properties comparable to the imported vaccine and suggest that it may be a potential candidate for future vaccine development."

Journal • Hepatitis B • 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

Hepatitis B Vaccine Compliance and Seroresponse Rates Among Solid Organ Transplant Recipients Receiving Recombinant versus Adjuvanted HBV Vaccine (WTC 2025) - "Subjects that received Engerix-B (GSK) or Recombivax-HB (Merck) were categorized as recombinant HBV vaccine, while those who received Heplisav-B (Dynavax) were categorized as adjuvanted HBV vaccine...HBV vaccine type was unknown for 23.2% (n=92), while 4.5% (n=18) received Twinrix (Hep A/B)... HBV vaccination rates remain suboptimal in SOTR. There was a trend towards higher HBV vaccine completion rates with adjuvanted HBV vaccine. While there was no difference in seroresponse between adjuvanted and recombinant HBV vaccination, seroresponse rates to adjuvanted HBV vaccine were lower in this cohort than those achieved in phase 3 clinical trials (over 90%)."

Clinical • Compliance • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III) (clinicaltrials.gov) - P3 | N=540 | Not yet recruiting | Sponsor: PT Bio Farma | Trial completion date: Aug 2024 ➔ May 2026 | Trial primary completion date: Jul 2024 ➔ May 2026

Trial completion date • Trial primary completion date • Hepatitis B • Infectious Disease • Inflammation

IRHBRVD: The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort (clinicaltrials.gov) - P=N/A | N=240 | Recruiting | Sponsor: National Taiwan University Hospital | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Jul 2024 ➔ Dec 2027

Trial completion date • Trial primary completion date • 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=122 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed | Phase classification: P1 ➔ P1/2

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

Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (clinicaltrials.gov) - P1/2 | N=290 | Active, not recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Infectious Disease

A three antigen hepatitis B vaccine induces T cells to Pres1 and Pres2 which correlate with anti HBs antibody titers: An investigation into the immunological mechanisms contributing to high anti-HBs titers. (PubMed, Vaccine) - P3 | "PreHevbrio® is a 3-antigen HBV vaccine (3-A-HBV) engineered to express the three HBV envelope proteins; the small 'S' hepatitis B surface antigen (SHBs or HBsAg), the middle pre-S2 + HBsAg (MHBs) and the large PreS1 + PreS2 + HBsAg (LHBs) antigens...Further, we demonstrate that the T cell responses significantly correlate with the higher observed anti-HBs titers and may contribute to the higher and more durable anti-HBs titers. This trial is registered at Clinicaltrials.gov (NCT03393754) and EudraCT (2017-001819-36)."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

FACTORS ASSOCIATED WITH HIGH TITER RESPONSE TO HBV VACCINE IN PRIOR VACCINE NON-RESPONDERS WITH HIV: THE BEEHIVE TRIAL (AASLD 2024) - "Prior data suggest that a CpG 1018 adjuvanted vaccine may improve response and achieve higher antibody titers which have historically been associated with greater vaccine durability... ACTG A5379 BEeHIVe (B-Enhancement of HBV Vaccination in PWH) trial included a 3-arm, open-label, 1:1:1 randomization comparing recombinant HepB-CpG (HEPLISAV-B®, Dynavax Technologies Corporation) using a 2- or 3-dose regimen to a 3-dose HepB-Alum vaccine (Engerix-B®, SKF) in PWH who failed to mount a response to prior non-CpG adjuvanted vaccines... In a study of PWH with prior HBV vaccine non-response, a 3-dose regimen of HepB-CpG yielded high seroprotection titers independent of most known factors associated with lower vaccine response. Black and Asian races and younger age were predictive of high titers thought to predict HBV vaccine durability, which will be evaluated after trial completion."

Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

ALTERNATIVE HBV VACCINATION STRATEGIES FOR BOTH COMPENSATED AND DECOMPENSATED CIRRHOTICS (AASLD 2024) - " HBV-vaccine naive cirrhotic subjects, aged 18-75, at two hepatology clinics were stratified into those with a history of decompensation versus those without a history of the same, and each group was randomized 1:2:2 to SD-standard dose-3 doses of 20 mcg of Engerix-B (alum adjuvant; GlaxoSmithKlein) at 0,1 and 6 months; HD-high dose-4 doses of 40 mcg of Engerix-B at 0, 1, 2, and 6 months; and HS- Heplisav- 2 doses of Heplisav-B (Dynavax) at 0 and 1 months, respectively. Seroprotection rates following HBV vaccination may be maximized in both compensated and decompensated cirrhotic patients by utilizing alternative vaccine strategies such as 4 doses of double strength standard HBV, or 2 doses of standard strength Heplisav-B with no compromise in safety. The percentage of patients achieving seroprotection was statistically highest in the group receiving HS, regardless of compensation status."

Diabetes • Fibrosis • Hepatitis B • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus • TLR9

Measuring Immunoglobulin Titers Among Healthcare Workers After Hepatitis B Vaccination: A Cross-Sectional Study in Kuwait. (PubMed, Cureus) - "Inclusion criteria included the completion of three doses of the HBV vaccine (Engerix-B recombinant vaccine, GlaxoSmithKline Biologicals, Brentford, UK)...Implementing these measures can enhance the effectiveness of HBV vaccination programs, reduce HBV incidence among HCWs, and contribute to a safer healthcare environment. Post-vaccination testing is essential to ensure the safety of all HCWs against HBV."

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

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B (clinicaltrials.gov) - P3 | N=640 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Study on New Strategies for Hepatitis B Virus Immunization (clinicaltrials.gov) - P=N/A | N=1169 | Completed | Sponsor: Wu Jiang

New trial • 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

Molecular and functional analysis of a hepatitis B virus genotype C infection in a vaccinated individual (EASL-ILC 2024) - "The present study investigates an acute HBV infection in a regular blood donor from Switzerland with a complete vaccination course (Engerix B; 2001/2002)... HBV genotype C infection was confirmed in a fully vaccinated individual and was associated with an efficient secondary anti-HBs response leading to transient viraemia without HBsAg and anti-HBc seroconversion over six months. This supported previous study suggesting that anti-HBs-only occult HBV infection was associated to vaccine escape. Infection may be related to low level of anti-HBs at the time of virus contact and aa variability in S epitopes between HBV C strain and HBV A2-derived vaccine."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

HIGH RATE OF SEROPROTECTION WITH HEPLISAV-B IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (DDW 2024) - "To our knowledge this is the first prospective observational study to demonstrate the efficacy of the Heplisav-B vaccine in IBD patients. In our study vaccination with the two dose Heplisav-B series achieved a seroprotection rate of 7 % in patients with IBD which is greater than what is reported in the literature for the currently accessible three-dose hepatitis B vaccine series (Engerix-B) at 4 %."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease

HIGH RESPONSE RATE WITH HEPLISAV-B IN HEALTH CARE WORKERS PREVIOUSLY NON-RESPONSIVE TO HEPATITIS B VACCINE (DDW 2024) - " This prospective open label study measured response rates to HepB-CpG series in HCW who have previously received at least 5 doses of HepB vaccine with aluminum adjuvant (Recombivax B or Engerix B) and were non-responsive (anti-HBs 5 doses HepB vaccine revaccination with HepB-CpG shows a 91% response rate. HepB-CpG vaccine is showing promising results for providing adequate protection against HepB to a wider population and should be considered the standard of care for adult HepB vaccine non-responders."

Diabetes • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Metabolic Disorders