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

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

Influenza vaccine for 2024-2025. (PubMed, Med Lett Drugs Ther) - No abstract available

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

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 2024 ➔ Aug 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

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

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

HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis (clinicaltrials.gov) - P1 | N=119 | Completed | Sponsor: Dynavax Technologies Corporation | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Hepatitis B • Nephrology • Renal Disease

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: Jul 2024 ➔ Dec 2024

Trial initiation 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

New P1/2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Isolation of camel single domain antibodies against Yersinia pestis V270 antigen based on a semi-synthetic single domain antibody library and development of a VHH-based lateral flow assay. (PubMed, Vet Med Sci) - "These data demonstrate the great potential of the semi-synthetic library for use in isolation of antigen-specific nanobodies and the isolated specific VHHs can be used in antigen-capture immunoassays."

Journal • Infectious Disease

Hepatitis B-CpG vaccine series for healthcare workers who are hepatitis B vaccine nonresponders. (PubMed, Clin Infect Dis) - "This prospective study enrolled healthcare workers (HCW) who were nonresponders following at least 5 doses of aluminum-adjuvanted hepatitis B vaccine received the 2-dose Heplisav-B (HepB-CpG) series. After two doses of HepB-CpG, 43/47 (91%) participants, and with 1 dose 41/49 (84%) responded. HepB-CpGcould be the preferred vaccine in HCW nonresponders."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B Regimen for Adults on Hemodialysis in the U.S. (PRNewswire) - "Dynavax Technologies Corporation...provided a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of effectiveness or safety of a four-dose regimen of HEPLISAV-B....The sBLA was comprised of clinical immunogenicity and safety data from the Phase 1 HBV-24 study..."

CRL • Hepatitis B • Infectious Disease

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

SEROCONVERSION RATE AFTER 3-DOSES OF HEPLISAV B IS BETTER THAN 2-DOSES IN PATIENTS WITH LIVER DISEASE: AN OPEN-LABEL, RANDOMIZED-CONTROLLED STUDY (DDW 2024) - P4 | "To date 110 (38 cirrhosis) have completed the study; 59 patients (19 cirrhosis) received doses and 51 (19 cirrhosis) received 3 doses. In the -doses group 44 (75%) patients and in the 3-doses group 47 (9 %) patients had a good response (p=0. 0 )."

Clinical • Fibrosis • Hepatitis B • Hepatology • Immunology • TLR9

Utility of a Third Heplisav-B Dose in Patients with Inflammatory Bowel Disease without Immunity Following Two-Dose Heplisav-B Vaccination. (PubMed, Am J Gastroenterol) - "In patients with IBD lacking HBV immunity despite two-dose Heplisav-B vaccination, administration of a third dose resulted in a 56.7% seroconversion rate. Our results suggest that administration of an additional Heplisav-B dose may be an effective strategy in patients lacking immunity despite primary two-dose vaccination."

Journal • Chronic Kidney Disease • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Metabolic Disorders • Nephrology • Renal Disease