Drugs / Hepatitis B vaccine
Hepatitis B vaccine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hepatitis B virus infection 1 milestone | |||||
| Filed | Other | PreHevbrio | hepatitis B virus infection | — | “December 2021: New Drug Submission (NDS) for the 3-Antigen HBV vaccine filed with Health Canada” vbivaccines.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Refused (EMA) | EU (EMA) | Hexyon | — | 2013-02-22 | europa.eu ↗ |
| Approved | EU (EMA) | Tritanrix HepB | — | 1996-07-19 | europa.eu ↗ |
Trials 52
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-07-03 | Brii Biosciences Limited | Results Brii Bio Announces Topline End-of-Treatment Data from Phase 2b ENRICH and ENHANCE Studies for the Treatment of Chronic Hepatitis B briibio.com ↗
End-of-treatment data from ENRICH demonstrated higher HBsAg loss rates, consistent with ENSURE Cohort 4, confirming the role of BRII-179 in priming immune responses for functional cure strategies |
| 2026-05-27 | Brii Biosciences Limited | Results Brii Bio Presents Late-Breaking Data from Its Phase 2 ENSURE Study at EASL Congress 2026, Further Supporting the Potential Role of BRII-179 in Achieving Durable Immunological Control of HBV briibio.com ↗
Data from Cohort 4 suggested that participants responding to prior BRII-179 treatment achieved the most robust functional cure outcomes, further supporting its potential clinical benefit |
| 2025-11-10 | Brii Biosciences Limited | Results Brii Biosciences Presents Late-Breaking Data from Ongoing Phase 2 ENSURE Study at AASLD 2025, Reinforcing BRII-179’s Potential as a Curative Treatment for Chronic Hepatitis B briibio.com ↗
Cohort 4 follow-up confirms durable h epatitis B surface antigen ( HBsAg ) loss at 24 weeks post end of treatment (EOT) in BRII-179 anti-HBs respon ders treated with elebsiran plus pegylated interferon alfa (PEG-IFNα) |
| 2025-11-07 | Brii Biosciences Limited | Results Brii Biosciences Announces Publication of Phase 2 ENSURE Study Results in Nature Medicine briibio.com ↗ |
| 2025-04-29 | Gilead Sciences | Results Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis gilead.com ↗
In hepatitis B (HBV), Gilead will present initial results from a Phase 1a study of a novel investigational therapeutic vaccine that shows early promise towards the goal of achieving a functional cure for HBV infection. |
| 2025-03-30 | Brii Biosciences Limited | Results Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179’s Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification briibio.com ↗
Preliminary d ata from Cohort 4 of the ENSURE study supports a novel enrichment strategy to utilize BRII-179 to identify patients who are immune responders and have the potential to achieve higher HBsAg loss at EOT |
| 2023-07-23 | Gilead Sciences | Results New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
At Week 48, the proportion of participants who were underweight decreased from 20.4% to 14.3%, while the proportion of normal weight participants increased from 67.3% to 73.5%, respectively. |
| 2022-06-09 | Sinovac Biotech Co., Ltd | Results SINOVAC科兴EV71疫苗益尔来福 ® 上市六年来临床研究回顾 sinovac.com ↗ |
| 2019-11-08 | Gilead Sciences | Results Gilead Announces New Data from Viral Hepatitis Research Programs at The Liver Meeting® 2019 gilead.com ↗
® (sofosbuvir/velpatasvir) resulted in a cure rate (SVR12) of 95 percent (97/102) in patients 12 to < 12 years="" old. |
| 2019-10-22 | VBI Vaccines Inc. | Results VBI Vaccines Announces Late-Breaker Poster Presentation at The Liver Meeting® 2019 vbivaccines.com ↗
The successfully-met co-primary endpoints of (i) non-inferiority of seroprotection rate in all subjects age 18+ who received Sci-B-Vac compared to Engerix-B, and (ii) superiority of seroprotection rate in subjects age 45+ who received Sci-B-Vac compared to Engerix-B; |
| 2019-10-02 | VBI Vaccines Inc. | Results VBI Vaccines Announces Late-Breaker Oral Presentation at IDWeek 2019™ vbivaccines.com ↗
Notably, Dr. Langley will highlight the two successfully-met co-primary endpoints and detailed seroprotection data in key patient subgroups, including by age group, gender, diabetic status, body mass index, and smoking status. |
| 2019-06-17 | VBI Vaccines Inc. | Results VBI Vaccines Announces Positive Top-Line Results from PROTECT, a Pivotal Phase 3 Study of Sci-B-Vac® vbivaccines.com ↗
The SPR in all subjects age ≥ 18 years who received Sci-B-Vac® was 91.4% compared with 76.5% for subjects who received Engerix-B® |
| 2019-04-08 | Sinovac Biotech Co., Ltd | Results 北京科兴EV71疫苗联合免疫研究成果受到国际广泛关注 sinovac.com ↗
结果表明联合免疫不会影响疫苗的免疫原性和安全性。 |
| 2017-10-17 | VBI Vaccines Inc. | Results VBI Vaccines Hepatitis B Data Selected as Presidential Poster of Distinction at The Liver Meeting® 2017 vbivaccines.com ↗
Immunization with Sci-B-Vac® resulted in rapid seroprotection after two Sci-B-Vac ® vaccinations, and high anti-hepatitis B surface antigen (HBsAg) geometric mean titers (GMTs). |
| 2012-05-09 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Data on DPC System and Hepatitis B Program at CLINAM 2012 arrowheadpharma.com ↗
Single-dose injections of hepatocyte-targeted anti-HBV siRNA DPCs in a replication-competent, transiently transgenic HBV mouse model resulted in a multi-log reduction of serum HBsAg and serum HBV DNA. |
All press releases naming this drug 27 releases
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 78 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hepatitis B vaccine | “Since 2009, the WHO recommends to administer hepatitis B vaccine within 24 hours of birth to prevent MTCT.” NCT04029454 ↗57“There are two vaccines provided in this study: hepatitis B vaccine measles-rubella combined vaccine” NCT03373656 ↗ “Hepatitis B vaccine（Each 1.0ml/HBsAg60 μ g. Shenzhen Kangtai Biological Products Co., Ltd）” NCT05451420 ↗ “three doses of 20 μg of the hepatitis B vaccine, in months 0, 1, 6” NCT04540653 ↗ “HBV (Hepatitis B vaccine)” NCT00262002 ↗ |
| Known as | Combined hepatitis A and hepatitis B vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02445703 ↗ |
| Known as | Engerix B | “Each group received 3 vaccine doses (on days 0, 28 and 56) of either 15 microg of MSP3-LSP, 30 microg of MSP3-LSP or of the Engerix B hepatitis B vaccine.” PMID 19855847 ↗ Oct 20092“children were given one of two different doses of the MSP3 antigen (15 microg or 30 microg) or a control vaccine (Engerix B).” PMID 19607731 ↗ Jul 2009 “ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age” NCT03673462 ↗ |
| Known as | GeneVac-B | “hepatitis B vaccine immunotherapy of common warts (GeneVac-B 10 ml vial, Serum Institute of India Ltd., Pune, India)” NCT05326152 ↗ |
| Known as | HABV | “Combined hepatitis A and hepatitis B vaccine (HABV)” NCT02445703 ↗ |
| Known as | HB vaccine | “OBJECTIVE: To compare the safety and immunogenicity of two dosages of recombinant hepatitis B (HB) vaccine administered to infants born to HB-uninfected and HB-infected mothers.” PMID 26144895 ↗ Jul 20151“However, a preponderance of data indicates that the protective efficacy of the HB vaccine can last for at least 5 to 10 years and a booster before 5 years is not necessary.” NCT00172328 ↗ |
| Known as | HbsAg | “hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321” NCT00354861 ↗ |
| Known as | HBV | “Licensed pediatric HBV vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.” NCT03246230 ↗ |
| Known as | hepatitis B antigen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00354861 ↗ |
| Known as | HEPATITIS B SURFACE ANTIGEN | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05028322 ↗ |
| Known as | Hepatitis B Vaccine (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00013871 ↗ |
| Known as | Hepatitis B vaccine, experimental formulation | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00697125 ↗ |
| Known as | Hepatitis B Virus Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05902624 ↗ |
| Known as | HepB | “HepB vaccine alone” PMID 32426309 ↗ Apr 2020 |
| Known as | HepB-BD | “hepatitis B birth dose vaccine (HepB-BD)” PMID 34206058 ↗ Jun 2021 |
| Known as | recombinant HB vaccine | “Three doses of 10 or 5 μg recombinant HB vaccine were randomly administered by 1:1 within 24 h after birth, at 1 month and at 6 months.” PMID 26144895 ↗ Jul 2015 |
| Known as | recombinant hepatitis B (HB) vaccine | “OBJECTIVE: To compare the safety and immunogenicity of two dosages of recombinant hepatitis B (HB) vaccine administered to infants born to HB-uninfected and HB-infected mothers.” PMID 26144895 ↗ Jul 2015 |
| Known as | recombinant hepatitis B vaccine | “We conducted a multicenter, randomized, double-blind, parallel-controlled trial including 352 hemodialysis patients who were centrally randomized in a ratio of 1:1 to receive a...” PMID 28803502 ↗ Aug 20171“20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6” NCT05099757 ↗ |
| Known as | recombinant hepatitis B vaccine (Saccharomyces cerevisiae) | “recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (1.0ml/HBsAg 60 per dose)” NCT05451420 ↗ |
| Modality | Vaccine | “hepatitis B vaccine group” NCT00000745 ↗ |
| Route | Intramuscular | “administered IM in the anterolateral area of the left thigh” NCT00262002 ↗ |