Heplisav-B (hepatitis B vaccine (recombinant), adjuvanted) / Dynavax, Bavarian Nordic - LARVOL DELTA

BOOST-9: TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: University of Maryland, Baltimore | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2026

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

CD4-DEPENDENT MECHANISMS DRIVE HEPLISAV-B MEDIATED HBSAG CLEARANCE AND ANTI-HBV IMMUNITY IN CHRONIC HBV CARRIER MICE (AASLD 2025) - "HEPLISAV-B, an FDA-approved HBV vaccine combining HBsAg with the TLR9 agonist CpG-1018, has demonstrated superior immunogenicity clinically. HEPLISAV-B effectively breaks immune tolerance in chronic HBV infection, leading to stable HBsAg clearance, suppressed viral production, and robust, durable anti-HBV humoral and cellular immunity. Our findings unequivocally demonstrate that CD4 T cells are critically essential for mediating these therapeutic effects. These results highlight HEPLISAV-B's strong potential as a promising therapeutic vaccine candidate for achieving functional cure in patients with chronic HBV infection."

IO biomarker • Preclinical • Hepatitis B • Hepatology • Infectious Disease • CD4 • CD8 • IFNG • PTPRC • TNFA

KINETIC CHARACTERIZATION OF HBV ACUTE INFECTION AND HEPLISAV-B TREATMENT IN RAAV-HBV MOUSE MODEL (AASLD 2025) - "HBV infection in rAAV-HBV infected mice is highly dynamic despite the absence of HBV spread. Minimum serum HBV DNA t1/2 in mice was estimated to be 3.5 days. Heplisav-B demonstrated effective therapeutic potential to suppress HBsAg in the rAAV-HBV infected mouse model."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Influenza vaccines for 2025-2026. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

Genomic evidence links human dengue cases with undetermined serotypes to sylvatic lineages. (PubMed, Trop Med Health) - "This study provides the first genomic evidence of a recent sylvatic DENV2 spillover into humans in Malaysia, likely undetected by standard diagnostics due to genetic divergence. These findings underscore the urgent need to enhance surveillance tools and explore the sylvatic transmission cycle's role in dengue epidemiology."

Journal • Dengue Fever • Infectious Disease • RAF1

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

BOOST-9: TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: University of Maryland, Baltimore | Trial completion date: Jul 2024 ➔ Apr 2026 | Trial primary completion date: Dec 2023 ➔ Oct 2025

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

TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (clinicaltrials.gov) - P1/2 | N=89 | Enrolling by invitation | Sponsor: Michael Hoelscher | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • 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

High Rate of Seroprotection With Heplisav-B in Patients With Inflammatory Bowel Disease. (PubMed, J Clin Gastroenterol) - "Heplisav-B achieved higher rates of seroprotection than those seen with 3-dose recombinant HepB vaccines in patients with IBD and may be the preferred option."

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

Hepatitis B vaccination with HepB-CpG in people living with HIV: a narrative review. (PubMed, Expert Rev Vaccines) - "This review explores recent research on the two-dose HepB-CpG (HEPLISAV-B) vaccine, which is a potential solution to the challenge of suboptimal immune responses to three-dose HBV vaccines (HepB-alum) in people living with HIV (PLWH)...HepB-CpG might be more immunogenic in vaccine-naive and vaccine-experienced PLWH. Both attributes make HepB-CpG a possible future standard of care for adult HBV vaccination in PLWH."

Journal • Review • Fibrosis • Hepatitis B • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Cancer • Liver Cirrhosis • Oncology • Solid Tumor

A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Universitätsklinikum Hamburg-Eppendorf | Trial primary completion date: Feb 2025 ➔ Feb 2026 | Trial completion date: Aug 2025 ➔ Jun 2026

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

TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (clinicaltrials.gov) - P1/2 | N=89 | Not yet recruiting | Sponsor: Michael Hoelscher | Initiation date: Dec 2024 ➔ May 2025

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

A Practical, Short, [18F]F-DOPA PET/CT Acquisition Method for Distinguishing Recurrent Brain Metastases from Radionecrosis Following Radiotherapy. (PubMed, J Clin Med) - "We reconstructed three volumes from the LM file: acquisition duration of 120 s (V120), 270 s (V270), and 10 min for the standard clinical volume (Vclin)...The AUC values were 97.6% in both cases. A simple, static [18F]F-DOPA PET/CT acquisition, starting 1.5 min after injection and lasting less than five minutes, permitted reaching excellent diagnostic performance (100% sensitivity, 91.7% specificity, and 97.6% AUC) in discriminating between RN and MP."

Journal • Oncology • Solid Tumor

Heplisav-B vs Standard Hepatitis B Vaccine Booster for Health Care Workers. (PubMed, Ann Fam Med) - "In this cohort, 1 booster achieved seropositivity for 92.7% (95% CI, 84.8%-97.2%) of the standard hepatitis B vaccine group and 99.4% (95% CI, 96.6%-100.0%) of the Heplisav-B group. Both boosters are likely to produce seropositivity in this population."

Clinical • Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Posttransplant HBV Vaccine Compliance, Seroprotection, and Kinetics of Hepatitis B Surface Antibody in Thoracic Organ Transplant Recipients. (PubMed, Transpl Infect Dis) - "Suboptimal compliance with HBV vaccination and poor vaccine-induced seroprotection occur in thoracic organ transplant recipients, regardless of the vaccine used. These findings underscore the necessity of enhancing vaccination strategies for SOT recipients."

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

Optimizing hepatitis B virus seroprotection in thoracic organ transplantation: The role of HepB-CpG (Heplisav-B) vaccination schedule. (PubMed, Vaccine) - "The vaccine schedule significantly predicts HBV seroprotection in adult thoracic organ transplant recipients. Our data supports the recommendation that pre-transplantation Heplisav-B to achieve HBsAb ≥10 IU/L is the optimal vaccination schedule to maintain an HBsAb level of ≥10 IU/L post-transplantation. Further studies are needed to determine whether this observation can be replicated in non-thoracic organ transplant recipients or pediatric populations."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pediatrics • Solid Organ Transplantation • Transplantation

Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Mercy Medical Center | Trial completion date: Jul 2024 ➔ Dec 2028 | Trial primary completion date: Jul 2024 ➔ Dec 2028

Trial completion date • Trial primary completion date • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

POST-TRANSPLANT HBV VACCINE COMPLIANCE AND SEROPROTECTION IN THORACIC ORGAN TRANSPLANT RECIPIENTS (AASLD 2024) - "However, data on post-transplant hepatitis B virus (HBV) vaccination compliance and vaccine-induced seroprotection from conventional recombinant hepatitis B vaccine (Recombivax HB) versus CpG-adjuvanted recombinant hepatitis B vaccine (Heplisav-B) are lacking. We observed suboptimal post-transplant HBV vaccine compliance and poor vaccine-induced seroprotection in thoracic organ transplant recipients, regardless of the vaccine used. This study's findings emphasize the need to explore alternative post-transplant HBV vaccination strategies to improve both compliance and seroprotection."

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

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

OPTIMIZING HEPATITIS B VIRUS SEROPROTECTION IN THORACIC ORGAN TRANSPLANTATION: THE ROLE OF HEPLISAV-B VACCINATION SCHEDULE (AASLD 2024) - "The vaccine schedule significantly predicts HBV seroprotection in thoracic organ transplant recipients. Completion of two doses of Heplisav-B vaccine pre-transplantation to achieve HBsAb ≥10 IU/L is crucial to achieve seroprotection post-transplantation. If it is not feasible to complete two doses of Heplisav-B pre-transplantation, initiating the first dose pre-transplantation followed by the second dose post-transplantation (strategy B) is preferable to administering both doses post-transplantation (strategy C) for achieving HBV seroprotection post-transplant."

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

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

Hepatitis B Vaccine Compliance, Serologic Response, and Durability in Adult Thoracic Organ Transplant Recipients. (PubMed, Clin Transplant) - "Although less than half of thoracic organ transplant candidates completed HBV vaccine series pretransplant, Heplisav-B provided a higher vaccine completion rate and seroprotection than the 3-dose Recombivax HB. Clinicians should also be aware of the increased loss of HBV seroprotection in thoracic organ transplant recipients with age ≥ 60 years and pretransplant HBsAb between 10 and 100 IU/L. Assessment of seroprotection after HBV vaccination should be prioritized during the pretransplant period."

Compliance • Journal • Retrospective data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation