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recombinant HBV vaccine (Hansenula Polymorpha)

✓ Approved

AIM Vaccine · Vaccine · Vaccine

What is recombinant HBV vaccine (Hansenula Polymorpha)?

recombinant HBV vaccine (Hansenula Polymorpha) is a vaccine developed by AIM Vaccine. It is approved for therapeutic indications via injectable (others).

Drug Profile

CompanyAIM Vaccine
Drug ClassVaccine, Large Molecules
RouteInjectable (Others)
StatusApproved

Therapeutic Indications

recombinant HBV vaccine (Hansenula Polymorpha) is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedSouthern African journal of HIV medicine2026-11-11

A retrospective study of HIV and hepatitis B co-infection at a tertiary hospital in the Western Cape province of South Africa.

Hugo Alida M AM, Lovelock Tamsin T, Taljaard Jantjie J JJ

HIV and hepatitis B virus (HBV) coinfection is a clinical concern because of shared transmission routes and accelerated liver disease progression. Data from sub-Saharan Africa (SSA) remain limited. To describe the clinical, laboratory, radiological, and outcome characteristics of adults with chronic HIV/HBV coinfection attending a tertiary hospital in South Africa. A retrospective observational study of adults with HIV and chronic HBV infection attending an infectious diseases clinic between 01 January 2019 and 31 October 2024. Chronic HBV was defined as hepatitis B surface antigen positivity for at least 6 months. Eligible patients had at least two clinic visits. Data were extracted from clinical, laboratory, imaging, and pharmacy records. Of the 179 patients screened, 140 met inclusion criteria. The cohort had a female predominance of 51.4% and a median age of 42 years; most were diagnosed through routine HIV care. The median CD4 count was 214 cells/μL, and many had advanced immunosuppression. Most were receiving antiretroviral therapy (ART), with 78.8% on tenofovir (TDF)-based regimens. HIV and HBV viral load (VL) was low, and the median HBV VL was 81 IU/mL. Liver assessment showed that 36.3% had an abnormal Aspartate Aminotransferase to Platelet Ratio Index score and 40.2% had an elevated liver stiffness measurement (> 7 kPa) suggestive either of significant fibrosis or cirrhosis. Fifteen patients died, 3 of whom died from HBV-related causes. Retention in care was poor, with only one-third remaining in follow-up. Chronic HBV remains an important comorbidity among people living with HIV in South Africa, particularly in those born before widespread vaccination. Despite high ART coverage, important gaps remain in fibrosis assessment and retention in care. Strengthening prevention, vaccination, diagnostic access, and continuity of care is essential to reduce HBV-related morbidity and mortality.

PubMedInfectious agents and cancer2026-11-11

Evolutionary and functional landscape of HBx mutations in genotype D1 HBV: comparative insights from acute infection, chronic hepatitis, and HCC.

Jalali Kamyar Mazloum KM, Alkhawaja Ali Sameer AS, Xursandov Ilyos I, Gayratjon Elmurodov E et al.

HBV infection remains a major global health burden and a leading cause of hepatocellular carcinoma (HCC), with viral genetic variability contributing to the heterogeneity of clinical outcomes. Among HBV proteins, HBx functions as a multifunctional regulatory protein involved in viral replication, host transcriptional regulation, apoptosis, immune signaling, and oncogenic pathways. Although HBx biology has been extensively investigated, most mechanistic insights are derived from genotype B and C infections, while genotype D-particularly subgenotype D1-remains comparatively underrepresented. This narrative review provides an integrative synthesis of reported HBx mutational patterns across distinct clinical contexts of HBV infection, including acute infection, chronic hepatitis B, and HBV-related HCC, with particular emphasis on genotype D1-dominant populations from the Middle East. The review incorporates findings from previously published phase-specific studies together with relevant external literature to explore how HBx variability may relate to functional domains and disease-associated molecular patterns. Mutations are discussed in the context of major HBx functional regions, including the N-terminal regulatory region, the transactivation domain, the H-box/DDB1-binding motif, and the BH3-like region. Structural modeling, protein-protein interaction network analysis, and phylogenetic contextualization are used as conceptual and illustrative frameworks to interpret reported variants without inferring direct causality. Reported HBx variability appears to preferentially involve structurally flexible and interaction-rich regions. Recurrent substitutions, particularly involving glycine residues, are more frequently reported in acute and chronic infection settings, whereas HCC-associated variants more commonly involve C-terminal alterations and truncation events. Collectively, these observations support a hypothesis-generating framework in which HBx functional plasticity may reflect adaptive virus-host interactions under selective pressures rather than a linear oncogenic mechanism driven by individual mutations alone. Importantly, no new experimental or clinical data are presented, and all interpretations are derived from previously published studies and in silico analyses. By emphasizing genotype D1-specific evolutionary characteristics and addressing a geographical gap in HBV research, this review may provide a useful conceptual basis for future functional investigations, genotype-stratified analyses, and translational studies in HBV-associated liver disease.

PubMedCurrent HIV research2026-11-11

Prevalence and Immune Impact of HBV, HCV, EBV, and Syphilis Coinfections Among People Living with HIV in Hubei Province, China (2019-2023).

Mei Fanghua F, Naz Wajeeha W, Cheng Dujuan D, Chen Tianlin T et al.

People living with HIV (PLWH) are disproportionately affected by viral coinfections, including hepatitis B virus (HBV), hepatitis C virus (HCV), Epstein-Barr virus (EBV), and syphilis, each capable of compounding immune impairment and increasing morbidity. Despite effective antiretroviral therapy (ART), the integrated burden of these coinfections and their immunological impact among PLWH in China remains incompletely characterised, particularly across the COVID-19 pandemic period. This retrospective cross-sectional study analysed routinely collected surveillance and laboratory data from five sites in Hubei Province, China, across three periods: 2019, 2022, and 2023. A total of 788 PLWH aged ≥18 years with confirmed HIV infection were included. HBV coinfection was defined by HBsAg positivity, HCV by anti-HCV seropositivity, EBV by detectable plasma DNA (>400 copies/mL), and syphilis by Treponema pallidum antibody seropositivity. Immune status was assessed using the CD4+/CD8+ ratio and T-cell subset indices. Multivariable logistic regression identified independent predictors of each coinfection and of immune impairment. Statistical analyses were performed using SPSS, with significance set at p < 0.05. The cohort was predominantly male (83.6%) and aged ≥50 years (52.3%). ART coverage was 92.4%, and virological suppression was achieved in 383/626 participants with available viral-load data (61.2%; 48.6% of the full cohort, N = 788). The overall prevalence of HBV and/or HCV coinfection was 25.9%; HIV-HBV was identified in 13.5%, HIV-HCV in 16.1%, and triple HIV-HBV-HCV in 3.7%. HIV-EBV coinfection was detected in 4.3% and syphilis seropositivity in 24.2%, the highest coinfection burden (T. pallidum antibody, not confirmed active infection). Coinfection prevalence differed significantly across surveillance periods; anti-HCV seroprevalence increased from 1.1% in 2019 to 21.3% in 2023, and syphilis seropositivity increased from 23.9% to 40.2% (both p < 0.001). In multivariable analysis, injecting drug use was the strongest independent predictor of HCV coinfection (aOR 28.56, p < 0.001), male sex and MSM transmission independently predicted syphilis (aOR 4.57 and 2.06, respectively, both p < 0.001), and older age predicted HBV coinfection. EBV coinfection was the only viral coinfection independently associated with a low CD4+/CD8+ ratio after adjustment (aOR 2.10, p = 0.046), while HBV, HCV, and syphilis were not. A high burden of viral coinfections that differed across surveillance periods of differing cohort composition was identified among PLWH in Hubei Province across 2019-2023, with syphilis representing the most prevalent coinfection. EBV was the only coinfection independently associated with immune impairment after adjustment for ART and demographic factors. Integrating syphilis screening and evaluating EBV monitoring alongside routine hepatitis surveillance warrant further investigation in this region.

PubMedJournal of viral hepatitis2026-11-11

Triple Elimination of HIV, Syphilis and HBV Mother-To-Child Transmission in Africa: From a WHO Initiative to a Respondent-Level Reality.

Vo-Quang Erwan E, Ndow Gibril G, Hiebert Lindsey L, Gupta Neil N et al.

PubMedFrontiers in veterinary science2026-11-11

Comparison of the pathogenicity of a Taiwan lineage 1 NADC30/34-like recombinant and a lineage 3 Betaarterivirus suid 2 in pigs.

Lai Yi-Fang YF, Lin Chao-Nan CN, Chiou Ming-Tang MT, Chang Yen-Chen YC et al.

Porcine reproductive and respiratory syndrome virus 2 (PRRSV-2; Betaarterivirus suid 2) causes porcine reproductive and respiratory syndrome, leading to severe economic losses in the global swine industry. Lineage 1 (L1) PRRSV-2 has emerged and become increasingly prevalent in North America and Asia. This study compared the pathogenic characteristics of a Taiwan NADC30/34-like L1 recombinant and a lineage 3 (L3) PRRSV-2 strain and evaluated their suitability for establishing an experimental infection model in growing pigs. Ten-week-old pigs were inoculated with either the NADC30/34-like L1 NPUST-107-844/2018 strain or the L3 SW2018001-YL strain via concurrent intranasal and intramuscular routes. Pigs inoculated with the L1 strain exhibited higher body temperatures and a greater frequency of fever during the early post-inoculation period than those inoculated with the L3 strain. However, no significant differences were observed between the groups in peak viremia, lung pathological scores, or plasma cytokine concentrations. These results indicate that the Taiwan L1 strain induced a more pronounced early febrile response but produced virological, pulmonary pathological, and systemic cytokine responses comparable to those induced by the Taiwan L3 strain. Collectively, these findings highlight the pathogenic diversity of circulating PRRSV-2 strains in Taiwan and for future experimental studies, including investigations of disease pathogenesis, therapeutic interventions, and vaccine development.

PubMedMedComm2026-11-11

Therapeutic and Prophylactic Agents for Viral Diseases: Current Status, Challenges, and Future Prospects.

Khan Sawar S, Nisar Ayesha A, Li Xiaoxu X, Yu Hao H et al.

Viral diseases remain a major global health challenge despite substantial advances in vaccination, antiviral therapeutics, and public-health interventions. However, current antiviral strategies are still constrained by important gaps, including rapid viral evolution, limited broad-spectrum efficacy, immune escape, antiviral resistance, incomplete durability of protection, and inequitable global access to prevention and treatment. This review provides a comprehensive and integrated overview of contemporary antiviral prevention and therapeutic strategies, spanning vaccines, monoclonal antibodies, direct-acting antivirals, host-targeted therapies, immunomodulators, RNA-based therapeutics, gene-editing technologies, and cellular immunotherapies. We discuss the mechanistic foundations, clinical applications, pharmacologic considerations, and translational challenges associated with each modality across major human viral pathogens, including HIV, HBV, HCV, influenza, SARS-CoV-2, RSV, Ebola virus, arboviruses, and herpesviruses. Particular emphasis is placed on emerging innovations such as long-acting prophylaxis, Fc-engineered monoclonal antibodies, nanoparticle and mucosal vaccine platforms, CRISPR-based antiviral systems, and broadly protective host-directed approaches designed to overcome resistance and enhance pandemic preparedness. In addition, we highlight the growing importance of real-time genomic surveillance and equitable global deployment strategies in shaping future antiviral responses, collectively underscoring that the next generation of antiviral medicine will depend on the convergence of universal immunization strategies, durable therapeutics, precision immune modulation, and rapidly deployable platform technologies capable of addressing both endemic and emerging viral threats.

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