HEPLISAV-B

BIOLOGICAL5 trials

Sponsors

Dynavax Technologies Corporation, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), Baylor Research Institute

Conditions

Chronic Kidney DiseaseHIV InfectionHepatitisHepatitis BPregnantSafety and Tolerability

Phase 1

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

CompletedNCT04199715

Baylor Research InstituteHepatitis B

Start: 2019-12-03End: 2022-01-20Updated: 2022-03-11

Phase 2

HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)

CompletedNCT03685708

National Heart, Lung, and Blood Institute (NHLBI)Hepatitis, Safety and Tolerability

Start: 2018-12-07End: 2020-12-16Updated: 2022-02-08

Phase 3

Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients

CompletedNCT00985426

Dynavax Technologies CorporationChronic Kidney Disease

Start: 2009-09-30End: 2012-01-31Updated: 2021-05-19

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

CompletedNCT04193189

National Institute of Allergy and Infectious Diseases (NIAID)Hepatitis B, HIV Infection

Start: 2020-12-14End: 2024-08-13Updated: 2025-07-20

Unknown Phase

DV2-HBV-27: Observational Pregnancy Registry

Dynavax Technologies CorporationPregnant

Start: 2021-02-21End: 2024-12-31Target: 300Updated: 2023-09-18

Related Papers

Hepatitis B Vaccination Histories in Persons with HIV Needing Revaccination.

2025-12-26

An efficient vaccine clinical trial: ACTG A5379 hepatitis B vaccine trial in persons with HIV

Vaccine2025-03-27

HepB-CpG vs HepB-Alum Vaccine in People With HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial.

2025-01-0121 citations

Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines

Blood2020-12-01134 citations