Hepatitis Vaccines For March 2023
The U.S. Centers for Disease Control and Prevention (CDC) says most hepatitis viruses can be prevented by vaccination. The five hepatitis viruses – hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E are distinct viruses and require specific vaccines. The CDC released updated hepatitis vaccination schedules for children, adolescents, and adults in 2023.
Hepatitis A Vaccines
The World Health Organization (WHO) published an updated position paper on hepatitis A vaccines in October 2022, reviewing the longer-term (3–7 years) and more than seven years) follow-up studies, including data on efficacy, effectiveness, and safety of multidose and single-dose regimens of inactivated and live attenuated hepatitis A vaccines in children and adults vaccinated during childhood.
Hepatitis B Vaccinations
And the CDC's Advisory Committee on Immunization Practices (ACIP) published 'Universal Hepatitis B Vaccination in Adults Aged 19–59 Years: Updated Recommendations of the Advisory Committee on Immunization Practices; the United States, 2022, April 1, 2022. Previously, on February 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an update, and the ACIP voted in the affirmative.
On March 10, 2023, the CDC published Recommendations for Screening and Testing for Hepatitis B Virus Infection.
Hepatitis C Vaccine
As of February 2023, there are no U.S. Food and Drug Administration (FD) approved vaccines targeting hepatitis C.
Hepatitis Vaccines 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® vaccine 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 antigens (HBsAg).
Twinrix Hepatitis Vaccine is indicated for active immunization against disease caused by the hepatitis A virus and infection by all known subtypes of the hepatitis B virus.
PreHevbrio® (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, the U.K, Canada, and the U.S.
Xiamen Innovax launched the hepatitis E vaccine Hecolin® in October 2012. The vaccine was approved by China's State Food and Drug Administration based on the phase III trial (NCT02189603). In addition, the US NIH notified Xiamen that its Investigational New Drug application of Hecolin (HEV-239) at the FDA became effective on January 12, 2019.
Sinovac Biotech Ltd. Healive®, the only WHO-prequalified hepatitis A vaccine from China. Since 2002, Healive has been registered in 21 countries and organizations worldwide and is authorized to be administered in 33 countries and regions to susceptible individuals over 12 months old.
Hepatitis Vaccine Candidates
HBAI20 vaccine candidate consists of a standard HBV vaccine to which the AI20 adjuvant is added.
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 combined with BRII-835, to enhanced B-cell and T-cell immunity. Initial data announced on February 15, 2023, suggest VBI-2601 and BRII-835 combination induced meaningfully stronger anti-hepatitis B surface antigen-specific T-cell and antibody responses compared to BRII-835 alone.
VTP-300 vaccine candidate utilizes Vaccitech's ChAdOx1-MVA prime-boost combination to elicit an immune response against HBV. Vaccitech's updated interim analysis includes data from the fully-enrolled phase 1/2 clinical trial of 55 patients with chronic HBV)with at least three months of follow-up. It shows that VTP-300 induced meaningful, sustained reductions of HBV surface antigen (HBsAg) in people with chronic HBV. Declines were most prominent in patients with lower baseline HBsAg. HBsAg is a hallmark of chronic HBV infection. Unfortunately, fewer than 10% of patients on current standard-of-care HBV therapies achieve sustained HBsAg decrease or loss, a state associated with a functional cure of the disease.
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. On Nov. 6, 2022, VIR announced results from Part A of the Phase 2 MARCH trial, including all three cohorts, demonstrating a mean HBsAg reduction of >2.5 log10 I.U./mL. These data showed that VIR-2218 and VIR-3434, an investigational HBsAg-targeting monoclonal antibody engineered to act as a therapeutic vaccine potentially, are additive in reducing HBsAg. In addition, the combination of VIR-2218 and VIR-3434 through up to 20 weeks of treatment in Part A was generally well tolerated. Combining the learnings from the VIR-2218 plus PEG-IFN-α trial with these encouraging new results has led to additional cohorts evaluating the triple combination of VIR-2218, VIR-3434, and PEG-IFN-α being added to Part B of the MARCH trial. Initial data from Part B are expected in the second half of 2023.
Antios Therapeutics' lead once-daily oral drug candidate for treating HBV ATI-2173 is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide for HBV in clinical development.
Hepatitis Vaccine Price
Hepatitis vaccine prices are posted by the U.S. CDC Price List. In addition, minors who meet at least one of the following criteria are eligible for the CDC's Vaccines for Children. Additional hepatitis vaccine discount information is posted at InstantRx™.
Hepatitis Vaccine News 2023
February 15, 2023 - VBI Vaccines Inc. announced interim data from the Phase 2 study evaluating the combination of VBI-2601 and BRII-835 in chronically infected HBV patients.
January 9, 2023 - Researchers are investigating TherVacB, a novel heterologous prime-boost therapeutic hepatitis B vaccine. In TherVacB, proteins prime the immune response, while for boost vaccination, the antigens are delivered by a viral vector. The benefit of heterologous prime-boost vaccination is more robust and longer-lasting immunity.
December 8, 2022 - Health Canada approved PreHevbrio™ for active immunization against infection caused by all known subtypes of hepatitis B virus in adults.
October 31, 2022 - Vaccitech plc announced the dosing of the first patients in HBV003, a Phase 2b clinical trial designed to evaluate the safety and efficacy of VTP-300 further when combined with a low-dose anti-PD-1 antibody in patients with chronic hepatitis B infection.
Acute Hepatitis in Children
The WHO, U.K., Europe, Canada, and the CDC have reported acute liver inflammation infections of unknown etiology among children since October 2021. As of February 2023, new reports are posted on this weblink.
