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recombinant HBV vaccine (Hansenula Polymorpha)

✓ Approved

AIM Vaccine · 疫苗 · 疫苗

什么是 recombinant HBV vaccine (Hansenula Polymorpha)？

recombinant HBV vaccine (Hansenula Polymorpha) 是一种疫苗，由AIM Vaccine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AIM Vaccine
药物类别疫苗, 大分子
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, AIM Vaccine

治疗适应症

recombinant HBV vaccine (Hansenula Polymorpha) 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

PubMedFish & shellfish immunology2026-08-04

Development of an oral Lactobacillus casei-based recombinant vaccine expressing GCRV-II multi-epitope fusion protein and its protective efficacy against grass carp hemorrhagic disease.

Chen Xijia X, Chen Yujiao Y, Wang Danwen D, Tang Jiayi J et al.

Grass carp hemorrhagic disease caused by grass carp reovirus (GCRV) results in severe economic losses in aquaculture. Vaccination is an effective strategy for controlling viral infections. The subunit vaccines are considered promising because of their safety, strong immunogenicity, and ease of production. In this study, antigenic epitopes derived from the outer capsid proteins VP4, VP5, and NS38 of GCRV genotype II (GCRV-II) were identified, and oral Lactobacillus casei recombinant vaccines were developed to evaluate their protective efficacy in grass carp. Based on sequence homology, epitope prediction and structural analyses, three dominant epitopes, VP4274-367, VP5105-336 and NS38143-338, were selected and fused into a recombinant protein. The immunogenicity of fusion protein was confirmed by enzyme-linked immunosorbent assay (ELISA). Injection of the fusion protein significantly enhanced the expression of immune-related genes, increased serum neutralizing antibody levels and reduced the expression of inflammatory cytokines. After GCRV-II challenge, the vaccinated fish showed a survival rate of 66.7%, compared with 6.7% in the injectable control group, and exhibited the lowest tissue viral loads among all groups. To develop an oral vaccine suitable for aquaculture, the fused epitope sequence was inserted into the secretory expression vector pVE5523 and expressed in L. casei. The recombinant strain showed high tolerance to heat and acidic conditions and stably colonized the intestine for up to 14 d. Oral administration of feed containing freeze-dried recombinant L. casei significantly upregulated immune-related genes (ifn1, cd4-2, mhc-Ⅱα,igm and igt) as well as lysozyme and complement C3 levels. After GCRV-II challenge, orally vaccinated fish reached a survival rate of 70%, much higher than the 23.33% survival observed in the oral control group, with significantly decreased tissue viral loads. These results demonstrate that the recombinant L. casei vaccine LC-VP4274-367-VP5105-336-NS38143-338 is a promising oral vaccine candidate for protecting grass carp against GCRV-II infection.

PMID 42546999
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PubMedMicrobial pathogenesis2026-08-04

Development and evaluation of a virus like particle based vaccine candidate against Indian Isolate of porcine circovirus 2d in pig.

Deb Rajib R, Maity Hemanta Kumar HK, Samanta Kartik K, Madhanmohan M M et al.

Porcine circovirus type 2d (PCV2d) is the predominant genotype etiological agent of porcine circovirus-associated disease (PCVAD), causes substantial economic losses to the swine industry worldwide, including in India. Since currently available vaccines are mainly based on the PCV2a genotype, which is unable to offer cross protective immunity against emerging PCV2d strains, development of PCV2d specific vaccine is necessary. In this study, an indigenous virus-like particle (VLP)-based vaccine candidate was developed using the capsid coding gene (orf2) of an Indian PCV2d isolate expressed in a baculovirus-insect cell system. Recombinant capsid protein expression and self-assembly into VLPs were confirmed by Western blotting and transmission electron microscopy. The purified VLPs showed favourable thermostability as well as pH stability and elicited strong humoral and cellular immune responses in in vivo porcine model. A delayed booster immunization strategy resulted in prolonged antibody persistence. In further, in vivo challenge study with virulent homologous PCV2d virus vaccinated animals were protected against PCV2 clinical signs. Further, absence of detectable viral DNA in swab and tissue samples, and markedly alleviated histopathological lesions compared with unvaccinated controls animals. Overall, these findings suggest that the indigenous PCV2d VLP vaccine candidate is highly immunogenic and provides protective immunity against homologous PCV2d challenge, highlighting its potential indigenous vaccine candidate for controlling PCVAD against PCV2d.

PMID 42546908
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PubMedVeterinary microbiology2026-08-04

Augmented innate and humoral immune responses enhance early and durable rabies protection by a CD40L-overexpressing rabies vaccine.

Xing Xiao X, Wang Yufang Y, Xiong Zhimin Z, Liu Die D et al.

Rabies is the only acute zoonotic infectious disease with a mortality rate approaching 100%. Large-scale immunization of animals represents the most effective strategy for preventing human rabies. Consequently, there is a pressing need for a vaccine that is economical, safe, and efficient for controlling rabies transmitted by animals. A recombinant rabies virus (rLBNSE-CD40L) overexpressing murine CD40L was constructed using the RABV reverse genetics system. The possible adverse effects of rLBNSE-CD40L were evaluated using growth curves, body weight changes, survival rates, and inflammatory cell counts. The immunogenicity of rLBNSE-CD40L was assessed by measuring virus-neutralizing antibodies (VNA) levels, antiviral protection rates, and antibody isotype levels in mice. Flow cytometry, RNA sequencing, and lymph node immunofluorescence were employed to investigate the innate and humoral immune responses induced by rLBNSE-CD40L. Notably, rLBNSE-CD40L was found to rapidly generate significantly higher VNA levels as early as three days post-immunization, which relies on the activation of dendritic cells (DCs) and the engagement of innate immune-related pathways and genes. This vaccine candidate enhances innate immunity and elicits persistent primary and secondary antibody responses by promoting T helper 1 (Th1)-biased and T follicular helper (Tfh)-dependent germinal center (GC) humoral immunity. In conclusion, our study suggests that rLBNSE-CD40L has the potential to be developed into a non-pathogenic and effective animal rabies vaccine.

PMID 42546450
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PubMedVaccine2026-08-04

Advances in clinical immunogenicity evaluation of influenza vaccines.

Xu Nan N, Wang Liangliang L, Zhao Chunhui C, Shen Yanru Y et al.

Influenza vaccination is an effective intervention for preventing severe influenza, and assessing its immunogenicity is a critical step in determining vaccine protective efficacy. With the widespread use of influenza vaccines-including split-virion, subunit, recombinant protein, and live attenuated formulations-methods for evaluating immunogenicity have grown increasingly diverse and complex. This article systematically examines the advantages and limitations of various immunogenicity assessment approaches for influenza vaccines. It draws upon multidimensional evaluation frameworks covering humoral, cellular, and mucosal immunity, incorporating analytical techniques such as hemagglutination inhibition assays, microneutralization assays, enzyme-linked immunosorbent assays, mucosal secretory IgA detection, enzyme-linked immunospot assays, and flow cytometry. Furthermore, clinical challenge trials evaluations play an essential role in elucidating the relationship between immunogenicity and protective efficacy. This paper aims to establish a systematic and comprehensive reference framework for the development and immunogenicity evaluation of influenza vaccines, thereby advancing vaccine design and the prediction of protective outcomes toward greater precision.

PMID 42546636
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PubMedHepatology international2026-08-04

Bepirovirsen induces innate immune proteins independent of HBV.

Delahaye Jared L JL, You Shihyun S, Fu Kai K, Van Buren Scott S et al.

Bepirovirsen, an antisense oligonucleotide that targets all hepatitis B virus (HBV) mRNAs, is in development for the treatment of chronic HBV infection. Clinical studies have demonstrated that bepirovirsen has multiple mechanisms of action, including lowering HBV DNA, reducing viral protein production, and inducing immune activation. Post hoc analysis of biomarker samples from three studies was performed to further characterize changes in soluble protein biomarkers after bepirovirsen dosing. Across three studies (CS3 [NCT02981602] in participants with chronic HBV infection; PFS [NCT06058390] and QTc [NCT06422767] in healthy volunteers) participants received bepirovirsen (150 mg, 300 mg, or 450 mg) or placebo. Longitudinal serum samples were taken for exploratory proteomics analysis. Relative expression of soluble proteins, including immune-related biomarkers, was measured, and differential expression was determined across arms. Clustering analysis was performed to identify kinetic patterns. Bepirovirsen induced significant, transient protein differential expression in the hours after dosing, while there were relatively minor changes in placebo. There were many similarities in protein biomarkers induced in CS3 participants with chronic HBV infection and in the two healthy volunteer studies. Additionally, bepirovirsen treatment increased abundance of many proteins to a higher degree with increasing dose. These findings strengthen the association between bepirovirsen treatment and changes in innate immune-related proteins and indicate that this effect does not require the presence of HBV. The kinetic patterns of protein expression suggest that there are multiple waves of protein induction, which could impact recruitment and activation of innate and adaptive immune cell types. NCT02981602, NCT06058390, NCT06422767.

PMID 42550463
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PubMedInfectious diseases (London, England)2026-08-04

Clinical and virological characteristics of hepatitis B virus genotype E infection: a case series.

Tiecco Giorgio G, De Francesco Maria Antonia MA, Zeneli Laert L, Gottardi Federica F et al.

Hepatitis B virus (HBV) genotype E, mainly found in sub-Saharan Africa, exhibits low genetic diversity, unique molecular markers and high recombination potential but remains under-studied. This study describes the clinical and virological characteristics, mutational profiles, antiviral treatment responses and phylogenetic data of patients with confirmed HBV genotype E infection in a tertiary-care centre in northern Italy. A retrospective monocentric study was conducted at ASST Spedali Civili di Brescia, Italy, from 2015 to 2023. Patients with documented HBV genotype E who underwent genotypic resistance testing (GRT) for clinical reasons were included. Direct sequencing of the S/POL region was used for genotyping and mutation analysis, interpreted via Geno2pheno [hbv] 2.0 and Stanford HBV resistance tools. Eight patients were identified, mostly male (62.5%) and of African origin (87.5%), with a median age of 38.5 years. GRT was performed in six (75%) patients because of persistent viremia despite antiviral treatment, five (83.3%) of whom were HIV/HBV coinfected with detectable HIV viral load. Lamivudine resistance mutations (L180M, M204V) were found in one (12.5%) case, tenofovir resistance-associated mutations (M267L/I) in two (25%) and immune escape mutations in three (37.5%), including T126I, D144E and G145R. Despite GRT, treatment was not modified in four (50%) patients due to poor adherence concerns. Therapy adjustments led to viral suppression in three (37.5%) cases. In our setting, HBV genotype E infections largely occurred among migrants from endemic regions. Although nucleos(t)ide analogues are effective across genotypes, suboptimal adherence may hinder viral suppression and promote resistance.

PMID 42547309
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