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hepatitis-B vaccine

✓ Approved

China National Pharmaceutical · RARB · 疫苗

什么是 hepatitis-B vaccine？

hepatitis-B vaccine 是一种疫苗，由China National Pharmaceutical研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)。

药物档案

公司China National Pharmaceutical
药物类别疫苗, 大分子
分子靶点RARB
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, China National Pharmaceutical

作用机制

分子靶点

hepatitis-B vaccine 作用于 1 个分子靶点：

RARBretinoic acid receptor beta (RRB2, HAP)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

hepatitis-B vaccine 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsHepatitis B✓ Approved

相关研究文献

PubMedVaccines2026-07-27

Hepatitis B Vaccination in People Living with HIV: Bridging the Immunological Gap.

Radi Christelle C, Abu Faraj Jana J, Idriss Jad J, Gromer Daniel J DJ et al.

Hepatitis B virus (HBV) infection remains a major driver of liver-related morbidity and mortality among people living with HIV (PLWH), yet vaccine-induced protection is frequently suboptimal. HIV-associated immune dysfunction, including CD4+ T-cell depletion, altered antigen presentation, impaired T follicular helper cell support, and B-cell dysregulation, reduces seroprotection after standard recombinant HBV vaccines and may limit durability of antibody responses. Vaccine response is further influenced by HIV viral suppression, age, comorbidities, prior vaccine history, and baseline HBV serologic status, including isolated hepatitis B core antibody (anti-HBc) and occult HBV infection (OBI) considerations. Although antiretroviral therapy (ART) improves vaccine responsiveness, many PLWH fail to achieve protective hepatitis B surface antibody (anti-HBs) titers (≥10 mIU/mL) after conventional schedules, or experience antibody waning over time. Current guidelines recommend HBV vaccination for all susceptible PLWH with post-vaccination serologic testing and revaccination for nonresponders. Persistent implementation barriers, including incomplete series, vaccine hesitancy, stigma, and logistical constraints, continue to limit real-world impact. Emerging clinical trial data support CpG-adjuvanted HBV vaccines (HepB-CpG/Heplisav-B) and intensified dosing and schedules (double-dose or four-dose regimens) to improve seroprotection and generate higher peak anti-HBs titers, which may enhance durability. This review synthesizes guideline recommendations, immunologic mechanisms of hyporesponsiveness, predictors of vaccine response, and practical strategies to optimize HBV vaccination in PLWH.

PMID 42506660
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PubMedVaccines2026-07-27

Advancing Global Hepatitis B Elimination: The Case for Using Maize as a Low-Cost, Heat-Stable, and Scalable Oral Vaccine.

Watanabe Muneaki M, Howard John A JA

Because hepatitis B virus (HBV) remains a major global health burden, innovative strategies are essential to achieve the World Health Organization's goal of eliminating viral hepatitis and closing persistent coverage gaps for injectable vaccines. While parenteral administration remains the gold standard for immunization, constraints such as cold-chain dependence and needle-associated barriers limit its reach, particularly in resource-constrained environments. This review summarizes work aimed at a plant-produced orally delivered vaccine as a transformative, scalable step towards global hepatitis B elimination. Early studies demonstrated proof of concept for the oral delivery of plant-produced hepatitis B vaccine candidates, including human trials using lettuce and potato as the host, but they were limited by low antigen yields and instability. In contrast, maize-produced antigens represent a significant advancement, achieving high levels of accumulation and utilizing the seed's natural desiccation physiology for bioencapsulation to protect the antigen from digestion in the gastrointestinal tract. Mechanistically, this platform enables timed antigen release in the duodenum, promoting M-cell uptake and CD103+ (cells expressing CD103 known as integrin alpha E) dendritic cell (DC) presentation, thus encouraging immunogenic programming over oral tolerance. In addition, defatting the grain by supercritical fluid extraction further improves antigen thermostability up to 45 °C for one month and ambient temperatures for one year, maintaining structural integrity under extreme conditions in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability guidelines. Current recommendations for immunization are for three parenteral administrations using the hepatitis B surface antigen (HBsAg). The primary dose is usually given shortly after birth as a part of a multivalent vaccine. Therefore, initial studies for the oral plant-based vaccine have focused on using an oral boost after the parenteral prime. Data to support this premise are summarized along with co-administration of an oral and parental administration to elicit a stronger immune response. By overcoming past issues related to dose density and stability, this scalable, needle-free platform offers a practical way to eliminate global hepatitis B virus (HBV) transmission, especially in resource-constrained environments.

PMID 42506615
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PubMedVaccines2026-07-27

Evaluation of Hepatitis B Vaccine Immunogenicity in Low-Birth-Weight Infants After Complete Immunization: The Impact of Postnatal Catch-Up Growth and Maternal-Neonatal Characteristics.

Shen Lu L, Tang Wanqin W, Xie Yan Y, Hu Ran R et al.

Background: Low-birth-weight (LBW, <2500 g) infants are at increased risk of suboptimal hepatitis B vaccine responses; yet, data on their immunogenicity patterns and modifiable determinants remain limited. This study aimed to assess hepatitis B vaccine immunogenicity in LBW infants and to examine whether postnatal catch-up growth and maternal-neonatal characteristics are independently associated with antibody levels. Methods: We enrolled 511 LBW infants who completed the recommended 3-dose hepatitis B vaccination series at 0, 1, and 6 months. Blood samples were collected 4-6 weeks after completion of the full vaccination series. Geometric mean concentration (GMC) and seroprotection rate (SPR, anti-HBs ≥ 10 mIU/mL) were evaluated. Catch-up growth was quantified as the change in weight-for-age Z-score between 6 and 8 months of age (ΔWAZ). Multivariable linear regression was used to identify independent predictors of log-transformed antibody titers, adjusting for gestational age, maternal hepatitis B surface antigen (HBsAg) positivity, maternal body mass index (BMI), maternal fasting glucose, maternal thyroid disease, infant hemoglobin at 6 months, and ΔWAZ. Results: The overall SPR was 99.41% (508/511), with a GMC of 1045.37 mIU/mL (95% CI: 916.24-1192.70). SPR remained consistently high across all subgroups. In multivariable analysis, ΔWAZ was not significantly associated with antibody levels (β = -0.063, p = 0.571). Maternal HBsAg positivity showed no significant association (β = -0.104, p = 0.792). Maternal thyroid disease was independently associated with higher antibody levels (β = 0.793, 95% CI: 0.213-1.373, p = 0.007). None of the other covariates reached statistical significance. Conclusions: Hepatitis B vaccination demonstrated high immunogenicity in LBW infants, with very high seroprotection rates. Postnatal catch-up growth did not independently influence antibody levels. The significant positive association between maternal thyroid disease and infant antibody response warrants further prospective investigation.

PMID 42506603
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PubMedVaccines2026-07-27

Getting the Hepatitis B Birth Dose Vaccine to Every Baby: A Rapid Scoping Review of Birth Dose Vaccine Delivery Strategies in Out-of-Facility Settings.

Knudson Sophia S, Meghani Ankita A, Shelley Katharine D KD, Mossie Muluneh Yigzaw MY et al.

Globally, coverage of the hepatitis B vaccine within 24 h of birth is 45 percent, far below the WHO target of 90 percent by 2030. For newborns delivered in out-of-facility settings, delayed contact with health workers, transportation barriers, and cold chain constraints can impede timely vaccination. This review explores strategies and facilitators for delivering birth dose vaccines to infants born outside of health facilities in low- and middle-income countries. A rapid scoping review was conducted, searching PubMed and targeted websites for peer-reviewed and gray literature published between 2005 and 2025. Data were charted using a standardized extraction tool. Frequency and thematic analyses were conducted. After screening 315 studies, 26 eligible sources were identified. Delivery strategies consisted of three components: identifying and tracking home births; supporting caregiver uptake through education, reminders, or incentives; and delivering the vaccine through home-based administration or referral to facilities. Sub-components included pregnancy and birth notification systems, postnatal home visits, mobile reminders, incentives, and home-based vaccination by facility or community providers. The feasibility of these strategies was shaped by factors across system levels, such as national policies and financing; health system infrastructure; cold chain capacity; health workforce configuration; caregiver awareness; and community social norms. In several contexts, flexible cold chain approaches and vaccine administration by community-based cadres enabled timely vaccination of infants born at home. Vaccination programs can learn from existing out-of-facility vaccine delivery approaches to strengthen hepatitis B birth dose vaccination programs for timely and equitable coverage.

PMID 42506591
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PubMedVaccines2026-07-27

Immunization Status and Effectiveness Analysis of Hepatitis B Vaccine Among Preterm Infants in Fujian Province, 2022-2023.

Zhang Hairong H, Zhang Jie J, Cai Zhikun Z, Huang Lifang L

Objective: This study evaluated hepatitis B vaccine (HepB) uptake, associated influencing factors, and post-vaccination immune responses among preterm infants residing in Fujian Province. The findings can support targeted improvements in hepatitis B prevention and control strategies tailored for this high-risk neonatal population. Methods: We conducted a multicenter cross-sectional study combined with short-term prospective serological follow-up across five counties, cities and districts of Fujian Province between 2022 and 2023. A total of 779 eligible preterm infants were enrolled in this study. We collected demographic information of participating mothers and infants, as well as complete HepB vaccination records throughout the study period. For 363 enrolled infants, we performed serological tests to detect hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (HBsAb) at 1-2 months after they completed the full HepB vaccination series. To explore factors linked to timely administration of the first HepB dose (HepB1), completion of the full vaccination course and HBsAb serostatus, we adopted a set of statistical approaches including descriptive statistics, the chi-square test (Fisher's exact test was used for groups with small sample sizes) and binary logistic regression. Results: The timely HepB1 vaccination rate among all preterm infants was 78.18%, while 63.80% completed the full vaccination schedule as required. In the serology cohort, the HBsAb positive rate was 90.91%, and 8.82% of infants showed double-negative HBsAg and HBsAb results, indicating susceptibility to HBV infection. Multivariate analysis identified multiple risk factors for delayed vaccination. Preterm infants were more likely to receive vaccinations late if their mothers tested HBsAg-negative (HepB1: OR = 25.231, 95%CI: 4.997-127.406; full-course HepB: OR = 2.440, 95%CI: 1.395-4.269), were delivered in county-level or lower-tier medical facilities (HepB1: OR = 3.724, 95%CI: 2.107-6.580), or were born via cesarean section (HepB1: OR = 3.460, 95%CI: 2.169-5.520; full-course HepB: OR = 1.954, 95%CI: 1.411-2.704). Additional risk factors included a gestational age below 34 weeks (HepB1: OR = 4.369, 95%CI: 1.894-10.081; full-course HepB: OR = 2.237, 95%CI: 1.148-4.359) and a birth weight less than 2500 g (HepB1: OR = 2.251, 95%CI: 1.397-3.629; full-course HepB: OR = 1.513, 95%CI: 1.065-2.150). Conclusions: Preterm infants enrolled from five regions in Fujian Province achieved robust immune protection following standard HepB vaccination. However, timely first-dose coverage and on-schedule full-course vaccination remain suboptimal in this cohort. Observed gaps in routine vaccination management at primary care settings highlight a key area for improvement in local hepatitis B prevention. Targeted standardized training for maternity care staff at county-level facilities, paired with a full-cycle follow-up system for preterm infant vaccination, may further strengthen hepatitis B mother-to-child transmission (MTCT) interruption in the study regions.

PMID 42506618
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PubMedVaccines2026-07-27

The Role of Human Viral Entry Receptor Mouse Models in Advancing Antiviral Antibodies and Vaccines.

Zuo Na N, Zheng Xin X, Ishaq Rameez R, Ren Deshan D et al.

Human viral entry receptor mouse models exist to overcome a fundamental experimental barrier: many clinically important viruses bind their human entry factors far more efficiently than the corresponding murine orthologs, leaving conventional mice unable to support authentic infection, physiological tissue tropism, or meaningful countermeasure evaluation. This review is organized around the receptor-humanization concept rather than around a single coronavirus model. Engineering strategies compared here include random transgenesis, endogenous-locus knock-in, minimal receptor-interface humanization, conditional and inducible expression, and transient vector-mediated delivery. Receptor systems covered span human angiotensin-converting enzyme 2 (hACE2)-dependent sarbecoviruses, human dipeptidyl peptidase 4 (hDPP4)-dependent Middle East respiratory syndrome coronavirus (MERS-CoV), human cluster of differentiation 4/human C-C chemokine receptor type 5 (hCD4/hCCR5)-dependentt human immunodeficiency virus type 1 (HIV-1), adenovirus receptor models, human intercellular adhesion molecule 1 (hICAM-1) rhinovirus systems, hepatitis C virus (HCV), hepatitis B virus (HBV), and hepatitis D virus (HDV) entry-factor models, measles receptor models, poliovirus receptor/CD155 (PVR/CD155) models, human scavenger receptor class B member 2 (hSCARB2) enterovirus systems, and human transferrin receptor 1 (hTfR1) arenavirus models. We then discuss how these platforms support antibody evaluation, Fc-effector analysis, vaccine protection, variant benchmarking, and safety assessment. These models yield the most reliable data when the experimental question is explicitly entry-dependent and when receptor expression level, anatomical distribution, pathology window, and immune context have all been independently validated. They are least informative when receptor expression is non-physiological, when disease readouts are driven by promoter artifacts, or when post-entry species barriers remain the dominant bottleneck. A validation-centered framework is therefore proposed to guide the selection of each model for the specific antiviral antibody or vaccine question it can legitimately answer.

PMID 42506651
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