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

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

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

A Randomized Controlled Study of Efficacy and Safety of Accelerated Versus Standard Hepatitis B Vaccination in Patients With Advanced CKD. (PubMed, Kidney Int Rep) - "The patients were randomly assigned to either a standard HBV vaccination regimen (Engerix B; 40 μg at 0, 4, 8, and 24 weeks) or an accelerated regimen (40 μg at 0, 1, 4, and 8 weeks)...In patients with advanced CKD, the accelerated HBV vaccination regimen demonstrated a significantly higher seroconversion rate at 12 weeks of vaccination. This finding suggests that the accelerated regimen is an effective option to achieve rapid seroconversion before initiating hemodialysis or before undergoing kidney transplantation."

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

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 2025 ➔ Dec 2026

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

Safety and immunogenicity of the co-administered Na-APR-1 and Na-GST-1 hookworm vaccines in school-aged children in Gabon: a randomised, controlled, observer-blind, phase 1, dose-escalation trial. (PubMed, Lancet Infect Dis) - P1 | "Co-administration of recombinant Na-APR-1(M74) and Na-GST-1 to school-aged Gabonese children was well tolerated and induced significant IgG responses. These results justify further evaluation of this antigen combination in proof-of-concept controlled-infection and efficacy studies in hookworm-endemic areas."

Journal • P1 data • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain

Loss of Serologic Response in Young People With HIV (PWH) Who Had Undergone HBV Revaccination (CROI 2024) - "Background: We previously have shown in a clinical trial that PWH who had achieved virologic and immunologic responses with ART and were randomized to receive three double-dose (40-µg) HBV vaccine (Engerix) achieved a significantly higher seroresponse rate (anti-HBs antibody titer ≥10 mIU/ml) and high-titer (≥100 mIU/ml) seroresponse rate than PWH who received three standard-dose (20-µg) HBV vaccine...Three double-dose HBV revaccination leads to more sustained seroprotection than standard-dose revaccination in PWH. For PWH who fail to achieve high-titer seroresponse after revaccination, annual follow-up of anti-HBs titers is recommended to detect the loss of seroprotection for HBV revaccination to be administered timely."

Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • CD4

Effectiveness of HBV Vaccination in Hemodialysis Patients Negative for Anti-Hbs (APASL 2024) - "Engerix-B 40 mg was administered at 0, 1, 2, and 6 months... Hemodialysis patients lacking anti-HBs achieved 70% response rate to HBV vaccination in HBV-naive and resolved HBV groups. HBV vaccination for hemodialysis patients without protective anti-HBs is thus feasible and should be routinely implemented."

Clinical • Hepatitis B • Hepatology • Inflammation • 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

Hepatitis B vaccination associated with low response in patients with rheumatic diseases treated with biologics. (PubMed, RMD Open) - "HBV vaccination response in patients with rheumatic diseases treated with bDMARDs was poorer than expected. Our data reinforce the recommendation for vaccination prior to starting bDMARDs."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US (clinicaltrials.gov) - P3 | N=2637 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Sep 2023 | Trial primary completion date: Oct 2024 ➔ Sep 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Meningococcal Infections • Pediatrics

Rapid Serologic Response of Patients with Advanced CKD to HepB-CpG Vaccination (KIDNEY WEEK 2023) - "There are 3 recommended HBV vaccines available in the US: Recombivax-HB, Engerix-B and Heplisav-B (HepB-CpG). In our real world clinical experience, HepB-CpG produces a rapid serologic response in advanced CKD patients requiring less doses compared to the high dose of the traditional HBV vaccines (Engerix or Recombivax-HB). Ongoing immunosuppression and active malignancy were the common causes of response failure."

Clinical • Metastases • Chronic Kidney Disease • Hematological Malignancies • Hepatitis B • Hepatology • Infectious Disease • Multiple Myeloma • Nephrology • Oncology • Renal Disease • Solid Organ Transplantation • Solid Tumor • Transplantation