This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has confirmed this vaccine to be more effective at inducing seroconversion as measured by development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be able to induce HBV viral control and/or seroconversion in chronically infected subjects

Start Date30 Sep 2024

Sponsor / Collaborator

Vaxine Pty Ltd.

NCT01951677

/ CompletedPhase 1

Phase 1 Randomized, Controlled, Double-blind Study to Compare the Safety and Effectiveness of Hepatitis B Vaccines in Individuals With Renal Impairment, Diabetes Mellitus or Age Greater Than 40 Years

There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development

Start Date01 Jul 2013

Sponsor / Collaborator

Vaxine Pty Ltd.

[+1]

100 Clinical Results associated with Hepatitis B vaccine(Vaxine Pty Ltd.)

100 Translational Medicine associated with Hepatitis B vaccine(Vaxine Pty Ltd.)

100 Patents (Medical) associated with Hepatitis B vaccine(Vaxine Pty Ltd.)

482

Literatures (Medical) associated with Hepatitis B vaccine(Vaxine Pty Ltd.)

01 Mar 2025·Asian Pacific Journal of Allergy and Immunology

Lessons from Thailand’s successful prevention of mother-to-child hepatitis B transmission: Advancing toward elimination by 2030

Review

Author: Jullapetch, Chatree ; Poovorawan, Yong ; Nilyanimit, Pornjarim ; Kanokudom, Sitthichai ; Inma, Phattharaporn

Thailand has achieved remarkable success in preventing and reducing hepatitis B virus (HBV) incidence through its nationwide newborn vaccination program, introduced in 1992 as part of the Expanded Program on Immunization (EPI). Before the vaccination era, HBV endemicity in Thailand was high, with a carrier rate of 6-8%, and mother-to-child transmission was a major route of infection. Early trials demonstrated the efficacy of hepatitis B vaccines, especially when administered within 12 hours of birth, followed by scheduled doses. The national vaccination program was initially piloted in two provinces in 1988 and expanded to full coverage by 1992. By 2024, carrier rates among children under 10 years dropped to less than 0.1%, meeting the WHO goal of zero mother-to-child transmission. Studies confirmed the vaccine's long-term protection, with no cases of chronic infection in vaccinated individuals with detectable anti-HBs over 20 years. Moreover, literature indicates that hepatitis B vaccination provides long-lasting protection more than 35 years. Additional measures, including antiviral use for high-risk mothers and expanded screening and treatment programs, have further supported HBV elimination. The program's impact has significantly reduced liver-related diseases and positioned Thailand as a model for HBV control. As the nation moves toward the 2030 hepatitis elimination goal, ongoing efforts focus on screening older populations with a high prevalence of infection and ensuring treatment access to achieve lasting eradication.

01 Feb 2025·Hepatobiliary Surgery and Nutrition

2024 latest report on hepatitis B virus epidemiology in China: current status, changing trajectory, and challenges

Review

Author: Yang, Huayu ; Sun, Minghao ; Mao, Yilei ; Sun, Lejia ; Du, Shunda ; Yan, Ruiyi

Hepatitis B virus (HBV) infection is a significant global public health concern, particularly in China, which accounts for one-third of the world's chronic HBV cases. Over the past three decades, China has made substantial progress in controlling HBV infection. Currently, the vaccination rate of the three-dose hepatitis B vaccine in China has risen to 99.6%, and the coverage of timely birth dose has reached 95.6%, significantly exceeding the global average level. The recent edition of chronic hepatitis B (CHB) prevention and treatment guideline has further expanded the treatment population to allow 94% of CHB patients meet the treatment criteria. With the complete immunization for newborns, in combination with antiviral treatment for HBV infected pregnant women, the mother-to-child transmission (MTCT) rate in China has decreased to 0.23%. The prevalence of hepatitis B surface antigen (HBsAg) has significantly declined to 5.86% in the general Chinese population. Specifically, among children under five years old, HBsAg prevalence showed the most significant reduction, from 9.67% in 1992 to 0.30% in 2020. However, challenges remain in achieving the World Health Organization (WHO)'s 2030 targets. In 2020, only 58.78% of HBV-positive individuals in China were aware of their status and 17.33% received antiviral therapy. The burden of HBV-related complications such as liver cirrhosis and hepatocellular carcinoma persists despite declining HBV infection rates. In this review, we analyzed the current status and evolving trajectory of HBV prevention and control in China, utilizing the latest data from national surveys, the Chinese Center for Disease Control and Prevention, and the WHO's 2024 report. We summarized the progress made, highlighted disparities, and outlined the persistent challenges and opportunities for HBV elimination. We recommend that future efforts focus on maintaining strict control of mother-to-child and bloodborne transmission, expanding screening strategies, improving early accessibility and diagnostic rates, addressing regional healthcare disparities, enhancing treatment accessibility and coverage, and ensuring timely antiviral therapy to ultimately achieve elimination goals.

01 Jan 2025·Vaccine

A three antigen hepatitis B vaccine induces T cells to Pres1 and Pres2 which correlate with anti HBs antibody titers: An investigation into the immunological mechanisms contributing to high anti-HBs titers

Article

Author: Anderson, David E. ; Soare, Catalina ; Hammond, Rachel ; Berthoud, Tamara K ; Petrov, Illia ; Ahmed, Tanvir ; Berthoud, Tamara K. ; Colledge, Danni ; Anderson, David E ; Yang, Lanjian ; Plaskin, Daniel ; Ontsouka, Barthelemy ; Diaz-Mitoma, Francisco ; Nadia, Warner

PreHevbrio® is a 3-antigen HBV vaccine (3-A-HBV) engineered to express the three HBV envelope proteins; the small 'S' hepatitis B surface antigen (SHBs or HBsAg), the middle pre-S2 + HBsAg (MHBs) and the large PreS1 + PreS2 + HBsAg (LHBs) antigens. 3-A-HBV has been shown to induce superior and more durable antibody responses relative to a 1-A-HBV despite containing half the 'S' antigen dose. To explain the mechanism(s) behind the high immunogenicity, the potential influence of mammalian glycosylation, HBs antigen conformation, anti-HBs epitope binding profiles and T-cell responses to the PreS antigens were investigated. In this paper, we demonstrate that glycosylation status does not play a role in the increased immunogenicity of the 3-A-HBV, but that the 3-A-HBV particles are able to induce T cell responses to PreS1 and PreS2 antigens. Epitope mapping demonstrated that the 3-A-HBV particles are inherently more antigenic than 1-A-HBV particles, leading to quantitative differences in the anti-HBs antibody response. Further, we demonstrate that the T cell responses significantly correlate with the higher observed anti-HBs titers and may contribute to the higher and more durable anti-HBs titers. This trial is registered at Clinicaltrials.gov (NCT03393754) and EudraCT (2017-001819-36).

100 Deals associated with Hepatitis B vaccine(Vaxine Pty Ltd.)

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B, Chronic	Phase 2	Australia	Vaxine Pty Ltd.	30 Sep 2024
Diabetes Mellitus	Preclinical	Australia	Vaxine Pty Ltd.	01 Jul 2013

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