Drug Database
HE

hepatitis-B vaccine

✓ Approved

Meiji Holdings · · Recombinant Proteins

What is hepatitis-B vaccine?

hepatitis-B vaccine is a recombinant proteins developed by Meiji Holdings. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

CompanyMeiji Holdings
Drug ClassRecombinant Proteins, Vaccine
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Meiji Holdings

Mechanism of Action

Molecular Targets

hepatitis-B vaccine acts on 1 molecular target:

(S)
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
Read full article →
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
Read full article →
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
Read full article →
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
Read full article →
PubMedVaccine2026-05-24

Evaluation of EcoCRM, virus-like particles, and mRNA as vaccine platforms against Borrelia burgdorferi.

Rocuskie-Marker Carleena M CM, Huckaby Annalisa B AB, Conaway Olivia M OM, Pyles Gage M GM et al.

Lyme disease (LD) is the most prevalent vector-borne disease in the United States, impacting ∼476,000 individuals annually with increasing incidence. Prevention relies on personal protective measures such as insecticides and tick checks, underscoring the need for new preventatives such as vaccines. In this work, the importance of vaccine platform in LD vaccine development efforts was evaluated using non-lipidated OspA as model antigen. Recombinant OspA conjugated to CRM197 (EcoCRM OspA), a virus-like particle vaccine utilizing SpyTag and SpyCatcher (OspA-SpyVLP), and an mRNA-based vaccine construct (OspA mRNA) were evaluated and compared in C3H mice using the needle injection challenge model. To determine immunogenicity, anti-OspA and anti-B. burgdorferi antibodies were quantified via ELISA and further assessed by measuring IgG subclass, antibody avidity, and presence of antibody secreting cells. All vaccine formulations were immunogenic and led to the release of similar levels of antigen-specific IgG in serum during the duration of the experiment. However, there were significant differences around two week post-boost in the presence of antibody secreting cells, ratio of IgG1/IgG2 subclasses, and antibody avidity between platforms. Protection was measured using PCR and darkfield microscopy to determine organ positivity post-challenge. Vaccination with recombinant non-lipidated OspA and OspA-SpyVLP significantly reduced the number of positive organs compared to the PBS challenged control group. Lastly, in vitro borreliacidal activity was quantified via darkfield microscopy and the highest borreliacidal activity was observed using OspA-SpyVLP sera, with titers 16-fold higher than recombinant OspA. Altogether, these data indicated that selection of vaccine platform/formulation influenced the immunogenicity and efficacy of OspA-based LD vaccines and should be considered during development.

PMID 42176436
Read full article →
PubMedAdvances in therapy2026-05-24

Efficacy and Safety of Pegylated Interferon as Rescue Therapy for Patients with Chronic Hepatitis B Who Failed to Achieve Functional Cure After Antisense Oligonucleotides or Small Interfering RNA: A Prospective, Multicentre, Open-Label Randomized Controlled Trial (SPHERE) Protocol.

Zhang Qiran Q, Sun Feng F, Sui Shulan S, Lin Jianmei J et al.

Although novel targeted therapies such as antisense oligonucleotides (ASO) or small interfering RNA (siRNA) can rapidly reduce hepatitis B surface antigen (HBsAg), only a subset of patients can achieve HBsAg seroclearance, and recurrence is common after discontinuation. This trial aims to evaluate the efficacy and safety of sequencing pegylated interferon alpha (Peg-IFNα) as rescue therapy for patients who have not achieved functional cure after initial therapy with ASO or siRNA. This is a prospective, multicentre, open-label, non-inferiority randomized controlled trial. Patients with chronic hepatitis B (CHB) who have previously completed a full course of ASO or siRNA therapy with HBsAg level of 1-500 IU/mL at screening will be enrolled. Participants will be randomized 1:1 to two arms: those in arm A (immediate treatment arm) will receive 24 weeks of Peg-IFNα starting at enrolment, followed by 24 weeks off-treatment observation; participants in arm B (delayed treatment arm) will firstly be observed for 24 weeks then followed by 24 weeks of Peg-IFNα treatment. At week 48, those with HBsAg seroclearance will enter a 48-week treatment-free follow-up, while those without seroclearance, regardless of initial arm, will receive an additional 24 weeks of Peg-IFNα, followed by 24 weeks off-treatment observation after week 72. The primary endpoint is the proportion of participants achieving HBV DNA < 20 IU/mL, HBsAg < 0.05 IU/mL and normal ALT at week 72. Secondary endpoints are HBsAg clearance rates, changes in clinical indicators, and safety evaluation results at other time points including weeks 24, 48 and 96. Sample size was calculated using Bayesian methods with the following parameters: experimental group response rate 0.57, control group response rate 0.47, non-inferiority margin 0.1, power 0.8, α = 0.05 and required posterior probability ≥ 80%. The single-group sample size was 33, and considering a 10% dropout rate, the total sample size was set to 72 (36 per group). Statistical analysis will be based on Bayesian non-inferiority test, with the primary judgment criterion being a posterior probability of ≥ 80% that the experimental group is non-inferior to the control group. Successful completion of this trial will provide a viable rescue treatment option for patients who have not met treatment goals after ASO or siRNA therapy. It may complete the future therapeutic framework, bringing more patients, especially those who are difficult-to-treat, within the scope of functional cure. ClinicalTrials.gov identifier NCT06923280.

PMID 42176181
Read full article →

+9996 more articles available with a free account

Sign up free to view all articles →

Ask about hepatitis-B vaccine