7 completed, 2 recruiting, 1 unknown. 4 Phase 1, 3 Phase 3, 1 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 3, Recruiting 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 2 | 1 | Completed 1 |
| Phase 4 | 1 | Recruiting 1 |
Follow Heplisav-B: new trials by email Literature Review of Heplisav-B trials Research Report on Heplisav-B
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] - Hepatitis B, Chronic Hepatitis B | Phase 1 | Recruiting | University of Maryland, Baltimore | 10 | 2025-10-16 | 2025-10-20 |
| A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate HEPLISAV B; TherVacB, TherVacB - Chronic Hepatitis B | Phase 1 | Completed | Universitätsklinikum Hamburg-Eppendorf | 26 | 2024-01-23 | 2026-06-04 |
| Vaccine Responses in Patients With B Cell Malignancies AREXVY, ABRYSVO, PREVNAR 20, PNEUMOVAX 23 - Lymphoma | Phase 4 | Recruiting | National Heart, Lung, and Blood Institute (NHLBI) | 350 | 2022-09-14 | 2026-08-04 |
| DV2-HBV-27: Observational Pregnancy Registry HEPLISAV-B - Pregnant | Unknown | Dynavax Technologies Corporation | 300 | 2021-02-21 | 2023-09-18 | |
| B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B HEPLISAV-B, ENGERIX-B - HIV Infection, Hepatitis B | Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 638 | 2020-12-14 | 2025-07-20 |
| Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients Heplisav-B - Hepatitis B | Phase 1 | Completed | Baylor Research Institute | 10 | 2019-12-03 | 2022-03-11 |
| HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis HEPLISAV-B® - End Stage Renal Disease on Hemodialysis (Diagnosis) | Phase 1 | Completed | Dynavax Technologies Corporation | 119 | 2019-04-22 | 2024-08-09 |
| HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I) HEPLISAV-B - Hepatitis, Safety and Tolerability | Phase 2 | Completed | National Heart, Lung, and Blood Institute (NHLBI) | 78 | 2018-12-07 | 2022-02-08 |
| Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine HEPLISAV, Engerix-B - Healthy | Phase 3 | Completed | Dynavax Technologies Corporation | 8374 | 2014-04-01 | 2019-03-20 |
| Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients HEPLISAV-B, Engerix-B, Placebo - Chronic Kidney Disease | Phase 3 | Completed | Dynavax Technologies Corporation | 521 | 2009-09-01 | 2021-05-19 |
Hepatitis B (7) · Hepatitis (4) · Hepatitis B, Chronic (2) · Kidney Failure, Chronic (2) · Disease (1) · HIV Infections (1) · Lymphoma (1) · Renal Insufficiency (1) · Renal Insufficiency, Chronic (1)
Dynavax Technologies Corporation (4) · National Heart, Lung, and Blood Institute (NHLBI) (2) · Baylor Research Institute (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · University of Maryland, Baltimore (1) · Universitätsklinikum Hamburg-Eppendorf (1)
United States (9) · Botswana (1) · Brazil (1) · Germany (1) · Kenya (1) · Malawi (1) · Philippines (1) · South Africa (1) · Thailand (1) · Uganda (1) · Vietnam (1)
Adrian U Wiestner, M.D. (1) · Christopher MT Pleyer, M.D. (1) · Kenneth E. Sherman, MD, PhD (1) · Kristen Marks, MD (1) · Lydia Tang, MBChB (1) · Marylyn M Addo, Prof (1) · Robert Perrillo, MD, FAASLD (1)
PMID 23727422, PMID 29289383, PMID 31431412, PMID 33259596, PMID 37017075, PMID 37353450, PMID 39616603, PMID 40147293
2009 (1)