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

Overcoming age-related tumor progression using the HEPLISAV-B vaccine in combination with immunotherapies (IMMUNOLOGY 2026) - "Treatment with the HEP B vaccine or a combination therapy can overcome age-related hurdles in tumor regression."

Combination therapy • IO biomarker • Breast Cancer • Hepatitis B • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • CXCR4 • IL15

Intratumoral administration of Sequential Heterologous Vaccine followed by intratumoral IL-15 complexes induces complete anti-tumor responses. (IMMUNOLOGY 2026) - "Leveraging the immunogenicity and unique compositions of vaccines traditionally employed against infectious agents, such as Shingrix (Zoster Vaccine Recombinant, Adjuvanted), and HEPLISAV-B (a CPG adjuvanted hepatitis B vaccine), may provide a unique opportunity to modulate the tumor microenvironment in TNBC. BALB/c mice with induced 4T1 tumors were treated intratumorally with a sequence of HEP B, SHINGRIX, and SHINGRIX (HSS) vaccines given on consecutive days intratumorally. Tumor growth kinetics revealed that the HSS Sequence significantly inhibited tumor growth, with 4 out of 5 mice remaining tumor-free 60 days post-tumor induction. These data suggest an optimized immunotherapeutic strategy combining vaccine sequencing with IL-15 complexes in TNBC. These data demonstrate the promise of in situ pathogen vaccine combination, either alone or in combination with IL-15 complexes, as a potent anti-cancer approach, eliminating the need for anti-PD1 therapy."

Hepatitis B • Hepatology • Herpes Zoster • Infectious Disease • Oncology • Triple Negative Breast Cancer • IL15

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

HEPLISAV-B Breaks Immune Tolerance and Induces HBV Control via CD4 T Cell-Dependent Mechanisms in a Chronic Hepatitis B Mouse Model. (PubMed, bioRxiv) - "To evaluate the therapeutic efficacy and immunological mechanisms of HEPLISAV-B, a CpG-1018-adjuvanted HBsAg vaccine, in breaking immune tolerance and inducing functional cure-like responses in a murine model of CHB. The findings support its potential as a therapeutic vaccine in CHB patients. What is already known on this topic: Chronic HBV infection is marked by profound virus-induced immune tolerance, current antiviral therapies and vaccines fail to reliably induce HBsAg loss or restore effective antiviral immunity, highlighting the need for immune-based therapeutic strategies.What this study adds: This study demonstrates that the clinically approved vaccine HEPLISAV-B can break HBV immune tolerance in a chronic HBV mouse model, inducing durable HBsAg clearance and anti-HBs immunity, non-cytolytic depletion of intrahepatic HBV DNA, through a mechanism strictly dependent on CD4 T cells and CD40/CD40L signaling.How this study might affect research, practice or policy:..."

IO biomarker • Journal • Preclinical • Hepatitis B • Infectious Disease • Inflammation • CD4 • CD40LG • CD8

Intratumoral administration of a single dose of the HEPLISAV-B Vaccine and IL-15 complexes induces tumor regression in Triple Negative Brest Cancer (IMMUNOLOGY 2026) - "Our findings indicate that the HEP B vaccine in combination with IL-15 is an attractive strategy to overcome immune checkpoint inhibitor resistance when added to ⍺PD-1 treatment in TNBC."

IO biomarker • Breast Cancer • Hepatitis B • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • CXCL9 • CXCR4 • IL15

A narrative review of immune-mediated adverse events in clinical trials of CpG oligonucleotide toll-like receptor 9 agonists. (PubMed, Vaccine) - "We review and evaluate immune-mediated adverse events from three sets of clinical studies using toll-like receptor 9 (TLR9) agonists (CpG-ODN) as vaccine adjuvants and therapeutic agents in patients with cancer: 1) a comparison of immune-mediated adverse events across phase 1-3 clinical trials of the hepatitis B vaccine HEPLISAV-B (HepB-CpG) with the alum-adjuvanted hepatitis B vaccine (HepB-alum); 2) an analysis of the rates of immune-mediated adverse events across clinical trials of COVID-19 vaccines using the CpG 1018 adjuvant; and 3) the rates of immune-mediated conditions in a study of the CpG-ODN nelitolimod (SD-101) combined with the immune checkpoint inhibitor pembrolizumab in patients with advanced melanoma or head and neck cancer, compared with rates in historical studies of pembrolizumab monotherapy. Data evaluated in this review show no increased risk for potential autoimmune disorders with HepB-CpG or CpG 1018-adjuvanted COVID-19 vaccines. Combining CpG-ODN..."

Adverse events • Journal • Review • Head and Neck Cancer • Hepatitis B • Immunology • Infectious Disease • Melanoma • Novel Coronavirus Disease • Oncology • Solid Tumor • PD-1

Mathematical modeling of HBV infection and HEPLISAV-B treatment in rAAV-HBV mouse model (EASL 2026) - No abstract available

Preclinical • Hepatitis B • Infectious Disease

Torque-Velocity is Associated With Voluntary Activation and Corticospinal Excitability in Healthy Knees, but Not Following Anterior Cruciate Ligament Reconstruction. (PubMed, J Sport Rehabil) - "Two-point torque-velocity relationships incorporating isometric contractions were associated with both voluntary activation and corticospinal excitability in healthy participants but not in ACLR limbs."

Journal

Drug Development. (PubMed, Alzheimers Dement) - "Our comprehensive NHP study will further validate this concept of immunomodulation as a safer approach to effectively ameliorate dementia-related pathology, particularly CAA, and support the potential clinical application of CpG-ODN 1018."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Dementia • Hepatitis B • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • GBP1 • GFAP • IFIT2

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