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

Vaccine-Derived HBsAg Antigenemia: A Diagnostic Pitfall in Occupational Health Screening (ACG 2026) - "To meet deadlines, the patient independently received a dose of Heplisav-B at an urgent care center four days before completing the ordered blood work...Recognition of this phenomenon is important as testing is performed shortly after vaccination. Clinicians should consider recent hepB vaccination in asymptomatic patients with unexpected HBsAg positivity and use HepB serology after antigen clearance to confirm the diagnosis."

Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Two Dose Hep-B-CpG vs Three Dose Hep-B-Alum Among People With HIV and Prior Vaccine Nonresponse: A Systematic Review and Meta-Analysis (ACG 2026) - "Recent recommendations suggest that nonresponders to the initial vaccination series should be reimmunized with two or three doses of HepB-CpG (Heplisav-B). However, large pooled data assessing whether full three-dose HepB-CpG booster series rather than two doses are enough to provide optimal immunoprotection compared with three doses of HepB-Alum vaccines (Engerix-B or Recombivax HB) among PWH remain limited... A total of 493 participants were included (248 HepB-CpG, 245 HepB-Alum). Mean age was 45 years; most were male. The cohort included White (46%), Black (37%), Asian (12%), and Hispanic (29%) participants."

Retrospective data • Review • Diabetes • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Metabolic Disorders • CD4

A real-world pattern on the long-term durability of the immune response to hepatitis B vaccination among people living with HIV in China: an 8.5-year retrospective study. (PubMed, Front Public Health) - "A total of 195 PLWH with baseline anti-HBs < 10 IU/mL who received ≥1 dose of Heplisav-B vaccine and underwent anti-HBs measurement at 7-9 months after the first dose were retrospectively analyzed...Multivariable analysis revealed the number of vaccine doses and a robust early serological response were consistent independent correlates of antibody persistence at 3.5, 5.5, and 8.5 years post-dose 1, with HIV RNA negativity additionally emerging as a key factor related to the 8.5-year outcome. These findings suggest that a complete 3- or 4-dose HBV vaccination series, coupled with an early serological response, is associated with sustained long-term antibody persistence in PLWH."

Journal • Real-world evidence • Retrospective data • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Adult immunization. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus • Varicella Zoster

Comparison chart: Some vaccines for adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Inflammation • Influenza • Measles • Meningococcal Infections • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

Hepatitis B Vaccination in People Living with HIV: Bridging the Immunological Gap. (PubMed, Vaccines (Basel)) - "Emerging clinical trial data support CpG-adjuvanted HBV vaccines (HepB-CpG/Heplisav-B) and intensified dosing and schedules (double-dose or four-dose regimens) to improve seroprotection and generate higher peak anti-HBs titers, which may enhance durability. This review synthesizes guideline recommendations, immunologic mechanisms of hyporesponsiveness, predictors of vaccine response, and practical strategies to optimize HBV vaccination in PLWH."

Journal • Review • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=350 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2026 ➔ Nov 2036 | Trial primary completion date: Aug 2026 ➔ Nov 2036

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

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=350 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | N=500 ➔ 350

Enrollment change • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (clinicaltrials.gov) - P1/2 | N=81 | Recruiting | Sponsor: Michael Hoelscher | Enrolling by invitation ➔ Recruiting

Enrollment status • Hepatitis B • Infectious Disease • Inflammation

A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Universitätsklinikum Hamburg-Eppendorf | Recruiting ➔ Completed | Trial primary completion date: Feb 2026 ➔ May 2026

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

Mathematical modeling of HBV infection and HEPLISAV-B treatment in rAAV-HBV mouse model (EASL 2026) - "Modeling suggests a significant suppression of HBsAg synthesis, which in turn reduces HBV DNA secretion, along with a moderate to high suppression of intracellular HBV RNA and HBeAg synthesis from Heplisav-B treatment in the AAV-HBV mouse model. Further experimental validation is required."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

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

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

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 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

Quantifying vaccine dissemination for uptake comparisons between vaccines. (PubMed, Hum Vaccin Immunother) - "The five vaccines were Arexvy, Comirnaty, Gardasil/Gardasil 9, Heplisav-B, and the ID Biomedical H1N1 Monovalent Vaccine. Collection, mapping, and analysis of estimated vaccine diffusion curves inform understanding of vaccine hesitancy and the impact of strategies and tactics to improve and accelerate vaccine uptake."

Clinical • Journal • Hepatitis B • Infectious Disease • Novel Coronavirus Disease

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

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

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