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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
Sources: ClinicalTrials.gov, China National Pharmaceutical

Mechanism of Action

Molecular Targets

hepatitis-B vaccine acts on 1 molecular target:

RARBretinoic acid receptor beta (RRB2, HAP)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

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

PubMedJournal of experimental & clinical cancer research : CR2026-05-24

Vaccine-expanded plasmablast-like B cells are associated with response to dendritic cell therapy in metastatic melanoma.

Tazzari Marcella M, Carloni Silvia S, Bulgarelli Jenny J, Pignatta Sara S et al.

Dendritic Cell Vaccines (DCVax) can induce tumor-specific immune responses, yet their clinical activity remains limited and poorly understood. We sought to identify cellular and molecular features within the vaccine product that are associated with clinical response to monocyte-derived DC vaccines in metastatic melanoma. We performed a multi-omics analysis integrating multiparametric flow cytometry, single-cell RNA sequencing of DCVax products, transcriptomic profiling of CD14⁺ monocytes from apheresis, and in situ characterization of pre-treatment melanoma biopsies. Patients were stratified into Responders (Rs) or Non-Responders (NRs) based on best overall response and Delayed-Type Hypersensitivity (DTH) status. An unanticipated population of CD19⁺ plasmablast-like B cells was identified within the final DCVax products. These B cells, phenotypically distinct from their circulating precursors, were significantly enriched in Rs and mirrored a B-cell-inflamed baseline state characterized by mature Tertiary Lymphoid Structures (mTLS) in pre-treatment tumor lesions. While mature LAMP3⁺ DCs appeared at comparable frequencies across outcomes, LAMP3⁺ DCs from Rs selectively upregulated HSPA1A/B, consistent with enhanced antigen-processing programs. Transcriptomic signatures of antibody production in vaccine-resident B cells, together with Fc receptor expression on DCs, support a model in which B-cell activity may contribute to antigen loading and DC functional tuning during vaccine manufacturing, a hypothesis that warrants functional validation. Our findings reveal a previously unrecognized B-cell component of DCVax biology, suggesting that cooperative DC-B-cell interactions, combined with baseline B-cell/mTLS features, may contribute to shaping vaccine immunogenicity. While causality cannot be established from the present data, these insights offer actionable avenues for enhancing both vaccine manufacturing and patient selection, extending beyond melanoma.

PMID 42177548
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PubMedInternational journal of food microbiology2026-05-24

Hepatitis E virus infection among raw pork products, pig feces, and human cases in Shandong Province, China: A prospective cross-sectional molecular study.

Zhu Xiaotian X, Lv Jingjing J, Feng Yi Y, Meng Xin X et al.

Zoonotic Hepatitis E virus (HEV) genotype 4 (HEV-4) has become the major pathogen responsible for acute viral hepatitis in China, with swine as the principal reservoir. This study aimed to further assess the presence of HEV in swine, raw pork products as food and genetic relationship with concurrent human strains in Shandong Province, China. From April 2023 to March 2025, a total of 358 raw pork products (166 livers, 96 kidneys, and 96 pork meat) from retail markets and slaughterhouses, 388 fecal samples from pig farms, and 110 serum samples from locally diagnosed HEV cases were collected. HEV RNA was detected using real-time RT-qPCR and nested RT-PCR assays. Overall, the detection rates of HEV RNA were 1.8% (3/166) in liver, 1.0% (1/96) in pork meat, and 6.5% (25/384) in pig feces, but not in kidney. Despite a low prevalence, the presence of HEV in commercial pig liver and pork meat represented potential vehicles for the virus to enter the food chain and a route of human HEV exposure. All 59 human and swine sequences obtained in this study were HEV-4. Human-derived sequences (n = 33) fell into subtypes HEV-4a, HEV-4b, HEV-4d, and HEV-4h, with HEV-4d predominated. Notably, all swine sequences (n = 26) were exclusively of the subtype HEV-4d, which clustered closely with local human HEV-4d strains and shared over 92% nucleotide identity. These findings advanced understanding of zoonotic transmission of HEV-4 from pigs to humans, underscoring the need to increase public awareness of hepatitis E as a swine-related foodborne disease.

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PubMedVaccine2026-05-24

Modelling the impact of long-acting monoclonal antibody, maternal vaccine and hybrid programs of RSV immunisation in temperate Western Australia.

Giannini Fiona F, Hogan Alexandra B AB, Blyth Christopher C CC, Glass Kathryn K et al.

Two RSV immunisations products: a maternal vaccine, Abrysvo, and a long-acting monoclonal antibody, nirsevimab, both designed to prevent RSV illness in infants, have recently become available. Modelling evidence is required to inform how to optimally use these products in immunisation programs to reduce the burden of RSV in young children. We extend a dynamic transmission model calibrated to RSV-hospitalisation data of children aged <5 years in temperate Western Australia (WA) to simulate a range of potential RSV immunisation programs. Using our model, we estimate the impact of both single-product and hybrid RSV immunisation programs. The analysis considers timing of administration, coverage levels and targeting of high-risk groups. Impact on RSV burden is analysed in the context of the WA setting and the possible significant cost differences between the two products. All programs analysed were effective in reducing RSV burden. Programs using nirsevimab for newborn infants at similar coverage levels to the Abrysvo programs, averted more RSV-hospitalisations annually. Seasonal programs that focused on protection during high RSV activity and programs targeting high-risk infants had the lowest number needed to immunise to avert one RSV-hospitalisation. When dose cost is considered alongside program impact on RSV burden, we find evidence to support further economic analysis of hybrid programs as they could mitigate the cost differential between the two products while remaining highly effective in reducing RSV burden. Our study is the first to comprehensively analyse hybrid RSV immunisation programs that use Abrysvo and nirsevimab. RSV immunisation programs can substantially reduce the burden of RSV in young children. Our modelling analysis provides evidence on immunisation type, timing, coverage, high-risk groups and dosage cost that will support decision makers and can be used in economic evaluations.

PMID 42176437
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PubMedVaccine2026-05-24

Consultation report - gonococcal immunoassays and standards for vaccine development.

MacLennan C A CA, Davis P P, Gottlieb S L SL, Seib K L KL et al.

Gonorrhoea is a sexually transmitted infection with adverse outcomes for sexual, reproductive and neonatal health. Additionally, the bacterium, Neisseria gonorrhoeae, has demonstrated increasing resistance against multiple classes of antimicrobials, making combatting gonorrhoea a priority for the World Health Organization. An effective vaccine would have substantial global public health benefit and a major impact on the silent pandemic of antimicrobial resistance. Several candidate gonococcal vaccines, representing a number of vaccine platforms, are in pre-clinical development. In addition, a number of clinical studies are underway to assess the efficacy of the meningococcal group B vaccine, 4CMenB, against gonorrhoea. A major challenge in comparing gonococcal vaccine candidates and vaccine-induced immune responses is the lack of standardised and harmonised immunoassays. At present, immunogenicity of the different vaccine formulations is measured through assays which have been developed independently in different laboratories. As the development of candidate gonococcal vaccines moves into clinical trials, improved harmonisation in the measurement of immunogenicity is key for comparing vaccine responses across trials. This requires international standards, including an international serum standard for gonococcal immunoassays, and a panel of standard target strains, which are currently lacking. A further complication is the lack of knowledge about immune correlates of protection against gonorrhoea, and, therefore, the most appropriate assays to use to assess the immune response to a candidate vaccine. As further data are gathered from clinical studies exploring protection against gonorrhoea provided by 4CMenB, it may be possible to discern correlates of protection, but this also requires standardised assays. A workshop was held at Keble College, Oxford, United Kingdom in April 2024, with participation from vaccine developers, regulators and assay standardisation specialists. Its goal was to advance discussions on gonococcal immunoassay standardisation priorities, including generation of a gonococcal international reference serum. The meeting discussion, outcomes and recommendations are outlined in this report.

PMID 42176439
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PubMedCurrent microbiology2026-05-24

Prevalence of Hepatitis B virus Genotypes and their Correlation with Serological Markers among Chronic Infected Patients in Sudan.

Yousif Ghanim Eltahir Ahmed GEA, Almorish Mohammed Aw MA, Musa Hassan Hussein HH, Elkhalifa Ahmed M E AME et al.

Hepatitis B virus (HBV) represents a significant global health issue, associated with elevated morbidity and mortality rates, particularly in African regions like Sudan, necessitating data on the prevalence of HBV genotypes and related biomarkers to enhance local and national prevention and control measures. This research aimed to clarify the frequency of HBV genotypes in chronic patients and their association with serological markers in four states of Sudan. A cross-sectional study was performed from December 2020 to February 2022 in Sudan. Among 385 patients positive for HBV, 200 were identified as chronic cases. Genotyping and viral load assessments via Polymerase Chain Reaction (PCR) and the INNO-LiPA techniques. Virological markers were evaluated using a standardized enzyme-linked immunosorbent assay (ELISA). Of the 385 patients with HBV in this study, 84.2% were male and 15.8% female, with 2.9% co-infected with HIV. A cohort of 200 individuals diagnosed with chronic HBV infection met the eligibility criteria. The prevalence of HBV genotype D was recorded at 92.5%, followed by the mixed genotype A/D at 4.5% and genotype A at 3.0%. Chronic HBV patients with D genotype exhibited normal liver enzyme levels, indicating a significant correlation with liver enzymes. Most negative hepatitis B envelope antigen (HBeAg) and positive HIV co-infection patients exhibited chronic HBV of the D genotype. The dominant genotype identified among patients with chronic HBV was genotype D, associated with higher HBeAg negativity, viral DNA loads of ≥ 10^3 copies/ml, normal liver enzyme activity, and concurrent HIV infection.

PMID 42177693
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PubMedInfectious diseases and therapy2026-05-24

HBV Serological Profiles and Vaccination Status in People with HIV in the Transition to a Tenofovir-Sparing Era: Insights from a Large HIV Cohort.

Foncillas Alberto A, De La Mora Lorena L, Berrocal Leire L, de Lazzari Elisa E et al.

The increasing adoption of tenofovir (TXF)-sparing antiretroviral therapy (ART) raises concerns regarding hepatitis B virus (HBV) susceptibility and reactivation risk among people with HIV (PWH). We characterized HBV serological profiles and vaccination status according to ART composition in a real-world cohort. A cross-sectional study of all PWH in active follow-up at Hospital Clínic, Barcelona, as of 30 June 2025. ART regimens were categorized as TXF-containing or TXF-sparing, with or without lamivudine (3TC). HBV serological patterns were classified as chronic infection, serologically resolved infection, isolated HBV core antibody (anti-HBc), no exposure/immunity, and vaccine-induced immunity. Demographic and clinical characteristics were compared using nonparametric and chi-squared/Fisher's tests. Among the 6437 participants included (82% cisgender men; median age 48 years [IQR 39-58]), 3519 (55%) received TXF-containing and 2918 (45%) TXF-sparing regimens, of whom 1702/2918 (58%) were with 3TC. HBV serological distribution was: 2% chronic infection, 26% serologically resolved infection, 5% isolated anti-HBc, 52% vaccine-induced immunity, and 15% without exposure/immunity (50% documented prior vaccination attempts, 32% nonresponders, and 31% with prior anti-HBs detection). Overall, 1280 (20%) lacked protective HBV immunity (isolated anti-HBc or negative serology for all markers), including 530 (41%) on TXF-free regimens. TXF recipients were younger (47 versus 50 years, p < 0.001), more often migrants (58% versus 49%, p < 0.001), had lower suppression rates (91% versus 97%, p < 0.001), a higher proportion of previous virological failure(s) (26% versus 21%, p < 0.001), and a lower number of prior ART regimens (median 3 versus 4, p < 0.001). One in five PWH lacked effective HBV immunity, including 41% of whom were receiving TXF-sparing strategies. In the context of increasing use of TXF-sparing strategies, improvements in systematic HBV screening, vaccination, and risk-based monitoring are essential to prevent HBV-related morbidity.

PMID 42176113
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