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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
Sources: ClinicalTrials.gov, AIM Vaccine

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

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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PubMedVeterinary parasitology2026-05-24

Recombinant PsoSP4 confers superior 80% protection against psoroptic mange in rabbits in association with a Th1-biased immune response.

Gu X B XB, Wu F Y FY, Hao G Y GY, JiPo E H Z EHZ et al.

Psoroptic mange, caused by Psoroptes ovis, is a severe global ectoparasitic disease for which no commercial vaccine is available. Here, we evaluated four recombinant P. ovis proteins (rPsoSP4, rPsoPRF, rPsoMIF, and rPsoSP5) as subunit vaccine candidates in a rabbit model. Three antigens conferred significant and graded protection, with final protection rates of 80% (rPsoSP4), 60% (rPsoPRF) and 20% (rPsoMIF), compared to 0% in the control and rPsoSP5-vaccinated groups. The lead candidate, rPsoSP4, reduced ear lesion scores, crust weights, and mite burden by up to 88.57%, 88.30%, and 81.80%, respectively. To our knowledge, rPsoSP4 is the most efficacious defined antigen against psoroptic mange reported to date, outperforming the previously tested single recombinant antigen and even a seven-protein cocktail vaccine. Mechanistically, protection correlated with a balanced, Th1-skewed immune signature. The high-level protection conferred by rPsoSP4 was characterized by elevated IFN-γ coupled with restrained Th-17A levels. In contrast, the non-protective rPsoSP5 vaccine elicited a singularly skewed Th17 response. Furthermore, antigen-specific IgG levels did not always correlate positively with protection (rPsoSP5), but a moderate yet significant elevation in total IgE was observed in the protected groups (rPsoPRF, rPsoMIF). This suggests a potential contributory role for IgE-mediated effector mechanisms in the anti-mite response. Our results identify rPsoSP4 as a highly efficacious single-antigen vaccine candidate and validate rPsoPRF and rPsoMIF as viable alternatives.

PMID 42176370
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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
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PubMedFish & shellfish immunology2026-05-24

Evaluation of the Immunological Efficacy of EsxA Subunit Vaccine and DNA Vaccine against Streptococcus iniae in golden pompano (Trachinotus anak).

Huang Zhiyuan Z, Sun Heng H, Wang Haoyu H, Jia Xinlei X et al.

Streptococcus iniae represents an important bacterial agent responsible for streptococcosis in marine fish, leading to substantial economic impacts in aquaculture worldwide. The development of effective vaccines is therefore a critical priority. EsxA, a conserved early-secreted and homolog of antigenic target six (ESAT-6), is involved in bacterial virulence and mediates interactions between the pathogen and its host via the type VII secretion system. In this work, EsxA was examined as a prospective vaccine antigen in golden pompano (Trachinotus anak) using both subunit and DNA vaccination strategies. Recombinant EsxA protein was expressed in Escherichia coli BL21(DE3) and administered intraperitoneally as a subunit vaccine, either alone or formulated with the oil-based adjuvant Montanide ISA 763A. Concurrently, a DNA vaccine was developed by cloning the complete esxA gene into the pVAX1 vector. Vaccinated fish were subjected to challenge with S. iniae at 8 weeks post-immunization to evaluate protective efficacy and assess the host's innate and adaptive immune responses. A high level of protection against S. iniae challenge was achieved with the EsxA-based subunit vaccine, particularly when formulated with adjuvant ISA 763A, whereas the DNA vaccine elicited moderate yet statistically significant protection. Immunological profiling revealed robust antigen-specific IgM production following subunit vaccination, while DNA vaccination significantly upregulated transcription of key immune-related genes associated with antigen presentation and cellular immunity, including MHC class I and CD8α. Furthermore, nonspecific immune parameters, including catalase, lysozyme, acid phosphatase, alkaline phosphatase activity and superoxide dismutase, were significantly elevated following vaccination, indicating potent activation of innate immune defense. Collectively, EsxA is a promising vaccine candidate against S. iniae in T. anak, and different vaccine platforms elicit distinct immune response profiles that may inform future vaccine optimization in marine aquaculture.

PMID 42176785
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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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PubMedAnnals of hematology2026-05-24

Prognostic model for diffuse large B-cell lymphoma based on an HBV-associated gene signature and immune microenvironment insights.

Zhao Guanhua G, Gao Sheng S, Liu Yalu Y

Diffuse large B-cell lymphoma (DLBCL) is the most common malignant lymphoma and exhibits significant clinical and molecular heterogeneity. Hepatitis B virus (HBV) infection has been associated with distinct clinicopathological features and an unfavorable prognosis in DLBCL. However, the molecular mechanisms underlying HBV-associated DLBCL and the remodeling of its immune microenvironment remain poorly understood. Through in silico analysis on transcriptomic data from the GEO and TCGA databases, we identified a set of prognostic HBV-associated differentially expressed genes (DEGs) in DLBCL and constructed a prognostic model based on these genes. A total of 72 HBV-associated DEGs were identified. From these, a 13-gene risk signature was constructed from univariate Cox regression and stepwise Akaike Information Criterion (stepAIC) optimization. This model successfully stratified patients into high- and low-risk groups, with differing survival analyses (GSE10846: risk HR = 2.38, p < 0.001; 3-year AUC = 0.753). A combined nomogram integrating clinical data with the HBV-derived signature maintained excellent discriminative ability (3-year AUC = 0.794) and calibration in the external datasets. Immune infiltration analysis revealed that compared to high-risk patients, low-risk patients had a greater total stromal and total immune cells, lower tumor purity, and a higher proportion of cytotoxic T and NK cells. In contrast, high-risk patients exhibited higher counts of M2 macrophages and immune checkpoint-expressing suppressive cells. The 13-gene model, linked to HBV biomarkers, establishes a novel computational framework for risk stratification in DLBCL and highlights key alterations in the tumor immune microenvironment associated with HBV infection. These findings provide a rationale for exploring immunotherapeutic strategies and elucidate the pathogenesis of HBV-related lymphomas.

PMID 42176052
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