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

Characterizing vaccine-induced dermatomyositis: a retrospective analysis of the Vaccine Adverse Event Reporting System (VAERS) (AAD 2026) - "Vaccines associated with a greater ROR were , Haemophilus Influenzae Type B (Hiberix) (ROR: 9.8468, CI: 1.3768 to 70.4220, P = 0.0227, Hepatitis B (Engerix-B) (ROR: 3.8394, CI: 1.9566 to 7.5339, P = 0.0001), Hepatitis B (Recombivax HB) (ROR: 3.4113, CI: 1.5970 to 7.2865, P = 0.0015), Human papillomavirus (Gardasil) (ROR: 3.9361, CI: 2.1298 to 7.2742, P < 0.0001), Influenza (H1N1 Monovalent - CSL) (ROR: 46.7436, CI: 6.5176 to 335.2408, P = 0.0001), , Meningococcal (Menomune) (ROR: 8.9761, CI: 1.2552 to 64.1911, P = 0.0288). Understanding which vaccines are associated with increased DM risk allows for informed conversations with patients on potential adverse events. Limitations to the study include self-reported data and limited sample size."

Adverse events • Retrospective data • Dermatomyositis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Myositis • Respiratory Diseases

Baseline Hepatitis B Immunity and Vaccination Booster Response Among Medical Residents: A Longitudinal Study in a Spanish Tertiary Hospital. (PubMed, Vaccines (Basel)) - "Residents with anti-HBs < 10 mIU/mL received an Engerix-B booster followed by repeat serology...Systematic baseline screening combined with targeted booster vaccination appears to be an effective strategy to ensure occupational protection. Further research incorporating cellular immunity markers may refine future vaccination policies and booster strategies."

Journal • Observational data • Hepatitis B • Infectious Disease • Inflammation • Measles • Preventive care

Immunogenicity of Hepatitis B Virus Vaccination in Relapsing-Remitting Multiple Sclerosis Patients Under Immunocompromising Treatment. (PubMed, Int J Mol Sci) - "We aim to analyse the response to the hepatitis B virus (HBV) vaccine (Engerix-B) in relapsing-remitting MS patients (RRMS) using these therapies because the scientific literature remains limited in this area...A lower vaccine response was observed in patients treated with immunosuppressive DMTs (51.8%, p < 0.001), particularly with fingolimod (32.4%, p < 0.001), and a higher response was seen with immunomodulators like teriflunomide and interferon-β1a (100%, p < 0.001). Using logistic regression, a model was obtained that included the number of vaccine cycles, lymphopenia and type of DMT associated with the response to the HBV vaccine. It is necessary to adapt HBV vaccination protocols for MS patients, considering the type of DMT used and baseline immune status."

Journal • Observational data • Retrospective data • CNS Disorders • Hepatitis B • Immunology • Infectious Disease • Inflammation • Multiple Sclerosis • IFNB1

CpG-Adjuvanted Heplisav-B Induces Strong Th1-Biased Innate Responses Compared to Alum-Adjuvanted HBV Vaccines in PLWH (IMMUNOLOGY 2026) - "While Heplisav-B's CpG 1018 adjuvant improves immunogenicity in PLWH, its mechanisms for overcoming HIV-related immune dysfunction are not yet defined. We performed multiplex cytokine/chemokine profiling assays and high-dimensional flow cytometry, including markers to interrogate cellular metabolism, to characterize early innate responses 24 hours after the first dose of Engerix-B or Heplisav-B in PLWH who were non-responders to prior HBV vaccination. Heplisav-B induced robust early innate activation, characterized by significantly elevated IP-10, MCP-2, and IFN-γ versus baseline, consistent with Th1-skewed inflammatory profile that was not observed following Engerix-B vaccination. Heplisav-B induces stronger Th1-skewed innate responses and increased B cell frequency than Engerix-B in PLWH within the first 24 hours of vaccination, while overall cellular composition and activation remain largely preserved. These findings provide mechanistic insight into how..."

Clinical • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • CCL8 • IFNG • IL17A • IL2 • IL4 • TLR9

Comparison of the Efficacy of Cell Wall Disruption Methods for Saccharomyces cerevisiae INVSc1 cells Expressing Toxoplasma gondii Recombinant ROP6 Protein. (PubMed, Protein Expr Purif) - "It supports post-translational glycosylation and is employed in several licensed vaccines, including hepatitis B (Engerix-B), human papillomavirus (Gardasil), and malaria (Mosquirix). Although Y-PER reagent yielded lower amounts of rROP6 protein compared to microfluidizer and acid-washed glass bead methods, it provided good protein stability by reducing multimerization and degradation and offered operational simplicity. Overall, the choice of disruption method should be guided by the target protein's characteristics, production scale, and cost considerations to optimize yield and stability."

Journal • Hepatitis B • Infectious Disease • Inflammation • Malaria • Oncology • Targeted Protein Degradation

COMBAT-HBV: The COMBAT HBV Feasibility Trial (clinicaltrials.gov) - P4 | N=317 | Completed | Sponsor: University of North Carolina, Chapel Hill | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • 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 | Completed | Sponsor: GlaxoSmithKline | Phase classification: P1/2 ➔ P1

Phase classification • Hepatitis B • Infectious Disease • Inflammation

Evaluating the Immunological Impact of Hepatitis B Vaccination in Patients with Inflammatory Bowel Disease. (PubMed, Int J Mol Sci) - "In this observational real-world study, 18 patients with IBD who were seronegative for hepatitis B virus (HBV) received three standard doses of the Engerix-B® vaccine (at 0, 1, and 6 months)...They also showed higher baseline Treg frequencies, which may suppress effective effector responses, together with impaired natural killer (NK) activation and progressive loss of memory potential. This study shows that hepatitis B vaccine failure in inflammatory bowel disease reflects a convergence of excessive immune regulation, inflammatory activation, and loss of memory potential, underscoring that no single pathway can explain the impaired response."

Journal • Observational data • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CCR2

Booster Vaccination Against Invasive Pneumococcal Disease and Hepatitis B in Previously Vaccinated Solid Organ Transplant Recipients Without Seroprotection. (PubMed, Vaccines (Basel)) - "Booster vaccination improved seroprotection against IPD, but not HBV. Further studies are needed to examine optimal vaccination strategies for SOT recipients."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pneumococcal Infections • Solid Organ Transplantation • Transplantation

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