The vision of the U.S. CDC is to eliminate viral hepatitis globally. The five hepatitis viruses – hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E – are distinct and can spread in different ways, affect diverse populations, and result in various health outcomes.
One dose of single-antigen hepatitis A vaccine has been shown to control outbreaks of hepatitis A successfully, says the CDC. And, the Advisory Committee on Immunization Practices (ACIP) recommends various people receive hepatitis B vaccination.
On September 29, 2021, the ACIP presented 'Should all unvaccinated adults receive hepatitis B vaccination,' by Kevin Ault, M.D.; Post-licensure safety of an adjuvanted hepatitis B vaccine: Final results of the HEPLISAV-B acute myocardial infarction study, led by Katia Bruxvoort, Ph.D. MPH; and 'Evidence to Recommendations Framework: Should all HepB-unvaccinated adults receive hepatitis B vaccination,' directed by Mona Doshani, M.D., MPH.
Hepatitis Vaccines - U.S. FDA Authorized
Engerix-B is a Hepatitis B Vaccine that is a noninfectious recombinant DNA hepatitis B vaccine.
Havrix Hepatitis A Vaccine is indicated for active immunization against disease caused by the hepatitis A virus.
Hecolin is a recombinant vaccine that contains the hepatitis E virus (HEV)-like particles prepared using a recombinant Escherichia coli expression system.
Heplisav-B combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR), nine agonists, to enhance the immune response.
Recombivax HB is a recombinant vaccine that contains synthetic Hepatitis B surface antigen (HBsAg).
Twinrix Hepatitis Vaccine is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus.
Hepatitis Vaccines Globally
Hepatitis E vaccine Hecolin® was launched by Xiamen Innovax in October 2012. The vaccine was approved by China's State Food and Drug Administration, based on the phase III trial (NCT02189603). Xiamen was notified by the US NIH that its Investigational New Drug application of Hecolin (HEV-239) at FDA became effective on January 12, 2019.
Hepatitis Vaccine Candidates
HBAI20 vaccine candidate consists of a standard HBV vaccine to which the AI20 adjuvant is added.
Sci-B-Vac is a third-generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S, of the hepatitis B virus—approved in Israel.
VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI's prophylactic 3-antigen HBV vaccine candidate and is designed to target enhanced B-cell and T-cell immunity.
VTP-300 vaccine candidate utilizes Vaccitech's ChAdOx1-MVA prime-boost combination to elicit an immune response against HBV. The HBV DNA sequence in the viral vectors is derived from a genotype C sequence, the most common genotype circulating worldwide.
VIR-2218 and VIR-3434 combination - VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S, and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all ten genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 "vaccinal mutation," allowing it to potentially function as a therapeutic T cell vaccine against HBV.
Hepatitis Vaccine News
October 14, 2021 - VBI Vaccines Inc. announced that results from the pivotal Phase 3 study, CONSTANT, of VBI's prophylactic 3-antigen hepatitis B vaccine candidate in adults age 18-45. VBI's vaccine candidate demonstrated robust and consistent immune responses across all three lots after two and three doses, with higher seroprotection rates and antibody geometric mean concentration compared to Engerix-B® No safety signals were observed. Together with results from the first pivotal Phase 3 study, PROTECT, these results formed the basis for the regulatory submissions of VBI's 3-antigen HBV vaccine candidate in the U.S., Europe, and Canada.
September 29, 2021 - The U.S. CDC Advisory Committee on Immunization Practices working group recommends that all adults unvaccinated against hepatitis B get vaccinated.
August 25, 2021 - An increase in hepatitis E and acute watery diarrhea cases has been seen in the camp for internally displaced persons in Bentiu, South Sudan. While we were treating an average of 230 patients per month throughout the year, we saw 1,454 in July - a 50% rise in the number of patients seen in June. The most affected are children aged under five years. The most affected are children aged under five years. No U.S. FDA-Approved vaccine for hepatitis E is currently available in the USA. However, in 2012, the Hecolin® recombinant vaccine from Xiamen Innovax was approved for use in China.
August 23, 2021 - The JAMA Network published an Original Investigation Comparative Efficacy of a High-Dose vs. Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIVA Randomized Clinical Trial. In this clinical trial, including 107 adults at a single HIV and hepatology clinic in Chile, 72% of patients receiving a high dose of HBV vaccine achieved serological response compared with 51% in the standard-dose group. In addition, more elevated and longer-lasting hepatitis B surface antibody titers were also seen in the high-dose group.
July 28, 2021 - World Hepatitis Day is commemorated yearly to increase awareness and understanding of viral hepatitis as a global priority. World Hepatitis Day has been observed annually since 2011, the birthday of Nobel-prize-winning scientist Dr. Baruch Blumberg, who discovered the Hepatitis B virus in 1967.
July 15, 2021 - Vir Biotechnology, Inc. announced that the first patient had been dosed in the Phase 2 MARCH trial evaluating VIR-2218 and VIR-3434 to treat patients with chronic hepatitis B virus infection – a combination designed to achieve a functional cure.
July 15, 2021 - New guidelines from the WHO strongly recommend offering self-testing for hepatitis C virus (HCV) as an additional approach to HCV testing services.
July 11, 2021 - A vaccine to protect against infection with hepatitis C could be in use within five years, says Professor Sir Michael Houghton.
July 9, 2021 - CDC MMWR: Unexpected Hepatitis B Virus Infection After Liver Transplantation — the United States, 2014–2019. 'During 2019, the Organ Procurement and Transplantation Network and CDC received an increased number of reports of HBV infection among liver recipients from HBV-negative donors; 12 of 14 implicated donors had evidence of recent injection drug use, and 13 donors were hepatitis C virus –seropositive.'
June 25, 2021 - Vir Biotechnology, Inc. announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus infection. The results demonstrate positive safety findings plus a reduction in hepatitis B surface antigen (HBsAg) for both compounds. In summary, data presented this week demonstrate the promising safety profile and the potential durable response of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), through 48 weeks. In a separate analysis evaluating VIR-2218 in combination with pegylated interferon alfa (PEG-IFN-α) for 12 weeks, a more rapid and substantial HBsAg decline was observed co-administration cohort compared to VIR-2218 alone. The treatment regimen resulted in no new safety signals.
June 24, 2021 - People living with the human immunodeficiency virus (HIV) are potentially at high risk of being infected with the hepatitis B virus (HBV), as both viruses share transmission routes. HIV/HBV coinfection has been associated with increased HBV DNA levels, accelerated liver disease progression, and increased all-cause and liver-related mortality. The prevalence of HIV/HBV coinfection in Spain at the end of 2018 was 3.2%, which does not differ significantly from percentages reported in studies performed over the past 15 years. All HIV/HBV-coinfected patients were on anti-HBV drugs and most of which HBV DNA was fully suppressed. Liver cirrhosis and HDV infection were identified as common problems among HIV/HBV-coinfected patients.
June 23, 2021 - Brii Biosciences and VBI Vaccines Inc. announced final results from a Phase 1b/2a study on BRII-179 (VBI-2601), a novel recombinant, protein-based immunotherapeutic candidate, in patients with chronic hepatitis B virus infection.
June 9, 2021 - Brii Biosciences announced that it would present the complete dataset from its Phase 1b/2a study evaluating BRII-179 (VBI-2601) as a treatment for chronic hepatitis B virus at the European Association for the Study of the Liver's International Liver Congress on June 23, 2021.
May 19, 2021 - The 2019 Viral Hepatitis Surveillance Report is published by the Division of Viral Hepatitis, Centers for Disease Control and Prevention. Data are presented for the cases of viral hepatitis infection from January 2019 through December 31 2019.
May 11, 2021 - The Lancet published a study: Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomized, double-blind, phase 3 trial. Interpretation - The safety and efficacy of the tri-antigenic hepatitis B vaccine show its usefulness for preventing HBV infection in adults, including those with stable and controlled chronic conditions. Funding - VBI Vaccines.
April 21, 2021 - Brii Biosciences, Vir Biotechnology, Inc., and VBI Vaccines Inc. announced that the first patient had been dosed in Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid-targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.
April 12, 2021 - VBI Vaccines Inc. announced data and next steps from the high-dose cohort of its Phase 1b/2a clinical study of VBI-2601 (BRII-179), the company's hepatitis B immunotherapeutic candidate, in chronically infected hepatitis B patients. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences as part of a potential functional cure for chronic hepatitis B virus infection.
February 24, 2021 - San Diego-based VLP BioTech, Inc. announced developing a more practical vaccine-based viral entry inhibitor to block HBV/HDV liver invasion. The company is seeking potential partners or licensees interested in this technology or combination therapies' clinical development.
February 19, 2021 - Dynavax Technologies Corporation announced that the European Commission had granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
February 2, 2021 - VBI Vaccines Inc. announced that the U.S. Food and Drug Administration had accepted its filing of the Biologics License Application for the Company's 3-antigen prophylactic hepatitis B vaccine candidate to prevent infection caused by all known subtypes of the hepatitis B virus in adults.
February 1, 2021 - Vaccitech Ltd. announced the dosing of the first patient in HBV002. HBV002 is a Phase 1b/2a clinical trial designed to evaluate the safety and preliminary efficacy of VTP-300 both with and without a low-dose anti-PD-1 antibody in patients with chronic hepatitis B infection. The study plans to enroll 64 patients in South Korea, Taiwan, and the UK.
January 25, 2021 - Atlanta-based Antios Therapeutics, Inc. announced that it had completed the Phase 1b clinical trial of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN), in patients with chronic hepatitis B virus infection. ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside's active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts HBV polymerase's active site, resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. In addition, ATI-2173 targets the liver, delivering high levels of the unique 5'- triphosphate while limiting systemic exposure to the parent L-nucleoside. Thus, ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.
January 15, 2021 - VBI Vaccines Inc. announced that results from a Phase 4 study of VBI's prophylactic 3-antigen Hepatitis B virus (HBV) vaccine in younger adults were published in vaccine, a journal publication from Elsevier. The study was designed to evaluate VBI's 3-antigen HBV vaccine's immunogenicity in support of that batch's qualification as a new reference standard for vaccine release to the Israeli market, where VBI's vaccine is available as Sci-B-Vac®.
January 12, 2021 - Gilead Sciences and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic combination strategies to develop a functional cure for the chronic hepatitis B virus. Anuj Gaggar, VP, Clinical Research, Virology at Gilead, stated, "We believe that selgantolimod and VIR-2218 have the potential to be best-in-class therapeutics and could provide a compelling new combination approach to a functional cure for HBV."
January 7, 2021 - The U.S. Department of Health and Human Services released a national plan to address the serious, preventable public health threat caused by viral hepatitis in the United States. The Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021–2025 sets national goals, objectives, and strategies to respond to viral hepatitis epidemics. Building on three prior National Viral Hepatitis Action Plans over the last 10 years, the Viral Hepatitis National Strategic Plan is the first to eliminate viral hepatitis as a public health threat in the United States 2030.
December 30, 2020 - A Maryland-based biopharmaceutical company announced that it had enrolled the first patient in its multinational Phase 2 clinical trial of HepTcell, a novel peptide-based immunotherapeutic under development to treat chronic hepatitis B.
December 15, 2020 - The U.S. Preventive Services Task Force published a final recommendation statement on screening for hepatitis B virus infection in adolescents and adults. Based on its review of the evidence, the Task Force recommends that clinicians screen teens and adults at increased risk of hepatitis B infection to help prevent serious health problems. "Screening teens and adults who are at increased risk for hepatitis B infection can help detect the virus and enable treatment to prevent serious health effects," says Task Force member Chyke Doubeni, M.D., M.P.H. "Evidence consistently shows that screening and early treatment leads to better health outcomes."
July 18, 2020 - The USA has been experiencing person-to-person outbreaks of hepatitis A in unprecedented numbers during the vaccine era. As of May 2020, 33 states had reported hepatitis A outbreaks involving approximately 32,500 cases reported by the Centers for Disease Control and Prevention.
February 3, 2020 - The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices published the revised Recommended Adult Immunization Schedule for 2020 in the Annals of Internal Medicine.
Note: This content has been reviewed by healthcare professions, such as Dr. Robert Carlson.