Drug Database
HE

hepatitis-B vaccine

✓ Approved

China National Pharmaceutical · RARB · Vaccine

What is hepatitis-B vaccine?

hepatitis-B vaccine is a vaccine developed by China National Pharmaceutical. It is approved for therapeutic indications via injectable (others).

Drug Profile

CompanyChina National Pharmaceutical
Drug ClassVaccine, Large Molecules
Molecular TargetRARB
RouteInjectable (Others)
StatusApproved

Mechanism of Action

Molecular Targets

hepatitis-B vaccine acts on 1 molecular target:

RARBretinoic acid receptor beta (RRB2, HAP)
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Therapeutic Indications

hepatitis-B vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedImmunological reviews2026-07-25

The Dual Role of Preexisting Immunity in Influenza: Protective Recall Versus Constraint of Novel Responses.

Fox Annette A, Zhu Ziheng Z, Sánchez-Ovando Stephany S

Preexisting immunity to influenza confers rapid protection against antigenically matched viruses but can also constrain responses to drifted variants. This review asks when and why prior infection or vaccination is protective versus detrimental, and which biological mechanisms-epitope masking by circulating antibody, inhibitory FcγRIIb signaling, and competitive dominance by affinity-matured memory B cells-drive these outcomes. We synthesize human cohort, serological, and vaccine-effectiveness data with mechanistic mouse and fate-mapping studies to explore how vaccine formulation, antigen dose, antigenic distance and T cell help modulate the balance between memory recall and recruitment of naïve B cells. Finally, we outline strategies (higher dose, adjuvants, multivalent display, and considered strain selection) to restore de novo responses against escape epitopes and improve vaccine performance.

PubMedOpen forum infectious diseases2026-07-25

Prevalence of Hepatitis B Coinfection in People With HIV by Birth-Year Cohort.

Lee So Jeong SJ, Verinumbe Tarfa T, Lesko Catherine R CR, Fojo Anthony A et al.

Availability of the hepatitis B virus (HBV) vaccine in the United States since 1982 and recommendations for universal/catch-up vaccination of infants and children since the 1990s may be associated with lower HBV prevalence among people with human immunodeficiency virus (HIV; PWH) born after 1980. Active HBV infection prevalence, defined as the proportion of patients with a positive hepatitis B surface antigen result, was assessed among PWH at entry into a clinical cohort. Patients were categorized into birth-year cohorts of 1940-1959, 1960-1979, or 1980-1999 and then further dichotomized into pre- and post-1980 birth-year cohorts. Log binomial regression was used to assess the association of birth-year cohort with hepatitis B surface antigen positivity, adjusting for race/ethnicity, HIV infection risk factor, baseline HIV viral load and CD4+ cell count, HBV active therapy, and year of/age at cohort entry. Among 5598 PWH, most were male (67%) and Black (77%), with a mean age (SD) of 39.7 (9.6) years at cohort entry. Approximately a third of the participants (30%) identified as men who have sex with men, and 39% reported a history of injection drug use. At cohort entry, the majority had a CD4+ cell count <350/µL and a viral load >1000 copies/mL. The HBV prevalence was 6.7% overall but varied by birth-year cohort: 6.2% for 1940-1959, 7.9% for 1960-1979, and 2.6% for 1980-1999. The risk of HBV infection was lower in the post-1980 than in the pre-1980 cohort (adjusted prevalence ratio, 0.19 [95% confidence interval, .09- .42]). PWH born after 1980 had a lower prevalence of HBV coinfection than those born before 1980, supporting the potential impact of universal childhood HBV vaccination.

PubMedJournal of the International AIDS Society2026-07-25

Vaccination Coverage and Prevention Counselling for Vaccine-Preventable STIs Among HIV PrEP Users in São Paulo, Brazil: A Retrospective Cohort Study.

Rapozo Marjorie Marini MM, Lara Amanda Nazareth AN, Passarelli Victor Cabelho VC, Ramos Laísa Rivas Dapousa LRD et al.

HIV pre-exposure prophylaxis (PrEP) users may be disproportionately vulnerable to sexually transmitted infections (STIs) in general, including several that are vaccine-preventable. Understanding immunization patterns in this population is, therefore, crucial. However, data on vaccination coverage among Brazilian PrEP users remains limited. We conducted a retrospective single-centre study of adults using HIV PrEP at an STI clinic in São Paulo, Brazil, between 2017 and 2024, to assess vaccination adequacy for vaccine-preventable STIs among PrEP users, as well as other STI prevention measures during follow-up. Demographic characteristics, substance use, STI history and vaccination status for hepatitis A (HAV), hepatitis B (HBV), human papillomavirus (HPV) and MPox were extracted from medical records, immunization registries and laboratory results, and descriptive analyses were performed. Among 190 participants (median age: 36 years), 89.5% were gay or other men who have sex with men (MSM). Over a mean follow-up period of 45 months, complete vaccination coverage was observed in 97.7% for HBV, 49.5% for HAV, 24.2% for HPV and 1.6% for MPox. Despite documented prior vaccination, a proportion of participants remained susceptible to HAV (16.3%) and HBV (2.3%). Furthermore, a substantial proportion of participants (32.1% for HAV, 53.7% for HPV and 81.0% for MPox) had neither a documented vaccination status nor a provider recommendation for vaccination recorded in their medical charts. HPV- and MPox-related clinical lesions were documented in 17.9% and 2.1% of participants, respectively. Notable gaps in immunization against preventable STIs were observed in this PrEP cohort in São Paulo, Brazil. While HBV coverage was high, uptake of HAV, HPV and MPox vaccines was low. Addressing these gaps in our cohort requires transitioning from mere provider recommendations to structural public health policies. Implementing on-site vaccine administration within PrEP services, integrating immunization into STI screening, expanding free access and addressing key vulnerabilities are critical steps to eliminate structural barriers and reduce the STI burden.

PubMedArchives of virology2026-07-25

HBV PreS/S gene mutations in patients with chronic hepatitis B.

Çakal Bülent B, Çavuş Bilger B, Atasoy Alp A, Bulakçı Mesut M et al.

Variants in the hepatitis B virus (HBV) PreS/S gene have been suggested to contribute to the development of progressive liver disease. This study aimed to evaluate the association between HBV PreS/S variations and liver histopathology in patients with chronic hepatitis B. A total of 109 patients under clinical follow-up for chronic hepatitis B were included. The HBV PreS/S gene was amplified by PCR and sequenced using the Sanger method. Amino acid substitutions, nonsense mutations, and deletions were analyzed in relation to liver fibrosis stage. Overall, 58 of 389 amino acid sites (14.9%) in the HBV PreS/S gene showed substitutions, with the highest mutation rate observed in the PreS2 region (27.27%). Mutations L54P (PreS1), F130L/S (PreS2), and S207R/N/I/T and I208T (S gene) were significantly more frequent in patients with advanced fibrosis (F ≥ 3) (p < 0.05). Multivariable analysis identified S207R/N/I/T as an independent risk factor for liver fibrosis. Patients with PreS2 mutations had higher fibrosis scores (p < 0.05). The S207R/N/I/T mutation in the C-terminal region of the HBV S protein is independently associated with liver fibrosis, while PreS2 mutations may contribute to fibrosis progression in chronic hepatitis B.

PubMedJournal of the International AIDS Society2026-07-25

Defining the Efficacy of Meningococcal B Vaccines Against Gonococcal Acquisition: The Current Landscape.

Seib Kate L KL, Grulich Andrew E AE

Gonorrhoea is a major global sexually transmitted infection, with rising incidence and increasing antimicrobial resistance threatening current control strategies. If untreated, Neisseria gonorrhoeae can lead to severe reproductive health sequelae. Gonorrhoea is also linked to increased HIV acquisition and transmission. There is currently no vaccine licensed to prevent gonorrhoea. However, observational evidence suggests that outer membrane vesicle-based serogroup B meningococcal vaccines, including the four-component meningococcal B (4CMenB) vaccine, confer partial cross-protection against gonorrhoea. We discuss observational studies and randomized controlled trials (RCTs) focused on defining the efficacy of 4CMenB against gonorrhoea. Observational studies from multiple settings have reported an association between receipt of 4CMenB vaccine and reduced gonorrhoea risk, with a meta-analysis estimating a 38% reduction in risk. Neisseria meningitidis and N. gonorrhoeae are closely related bacteria that share numerous antigens, making cross-protection biologically plausible. Based on observational data, 4CMenB immunization programmes have been implemented in two countries with the aim of preventing gonorrhoea. However, three RCTs have recently shown that 4CMenB is not effective in preventing gonorrhoea in gay, bisexual and other men at high risk of acquisition. Several RCTs are ongoing, looking at efficacy in different populations, including women and people at lower risk of acquisition. The different outcomes between the observational studies and RCTs may be due to a range of known and unknown confounding factors, and differences in the populations considered in the different studies. Current evidence from RCTs does not support the use of 4CMenB to prevent gonorrhoea in gay and bisexual men at high risk of acquisition. Results from ongoing RCTs will be critical to determine whether vaccine efficacy varies by population or epidemiological context and to inform future gonorrhoea vaccine policy and development.

PubMedCureus2026-07-25

Fatal Acute Liver Failure Associated With Presumed Hepatitis B Virus Reactivation During Rituximab Maintenance Therapy: A Case Report.

Tran James J, Zhou Calvin C, Babun Asis A AA, Leung Whinkie W et al.

We report a woman in her 60s with follicular non-Hodgkin lymphoma receiving maintenance rituximab therapy, last administered one month prior to presentation, who developed progressive malaise, jaundice, and acute liver failure. Laboratory evaluation demonstrated severe hepatocellular injury with marked transaminase elevations (alanine aminotransferase: 2,500 U/L; aspartate aminotransferase: 2,400 U/L), hyperbilirubinemia (total bilirubin: 20 mg/dL), and coagulopathy. Hepatitis B virus (HBV) serology demonstrated active infection with elevated hepatitis B surface antigen (HBsAg) and detectable HBV DNA. Baseline HBV screening and antiviral prophylaxis records prior to rituximab initiation were unavailable from the treating institution, limiting the definitive confirmation of pre-existing HBV status. Given the patient's recent rituximab exposure, clinical presentation, and exclusion of alternative etiologies, HBV reactivation was considered the most likely diagnosis. The patient was diagnosed with HBV reactivation associated with rituximab therapy. Despite the initiation of antiviral treatment and aggressive supportive care, her clinical course rapidly deteriorated, complicated by hepatic encephalopathy, acute kidney injury requiring hemodialysis, and hypoxic respiratory failure. She was evaluated for liver transplantation but deemed ineligible due to multiorgan failure and ultimately transitioned to end-of-life care. This case highlights the potentially fatal consequences of HBV reactivation during rituximab therapy and underscores the importance of appropriate screening, prophylaxis, and vigilance in high-risk patients.

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