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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

PubMedBiotechnology journal2026-10-26

Peroxisome Engineering for Overproduction of Sesquiterpenoid α‑Santalene in Ogataea polymorpha.

Xie Linfeng L, Shen Yiwei Y, Geng Zhi Z, Yu Fei F et al.

Santalene is the core aromatic component of natural sandalwood essential oil and the key precursor of santalol, which is a high-value sesquiterpenoid with unique woody aroma and bioactivities. Microbial production emerges as a promising alternative supply route other than inefficient plant extraction. Herein, we systematically engineer a peroxisomal factory for α-santalene overproduction in Ogataea polymorpha by optimizing mevalonate pathway in peroxisomes and enhancing the supply of reducing power NADPH and precursor acetyl-CoA. The engineered strain produced 556.2 mg/L and 3.4 g/L α-santalene in shake flask batch and fed-batch fermentations, respectively. This work suggests O. polymorpha is a promising host for peroxisome engineering and offers a sustainable bio-manufacturing route for santalol derivatives.

PMID 42928704
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PubMedNature communications2026-10-26

Reoviridae-derived short trimerization domain for stabilizing homo-trimerization of vaccine immunogens and therapeutic proteins.

Wei Min M, Bu Qingfang Q, Xiao Jin J, Yuan Lunzhi L et al.

Trimerization motifs play pivotal roles in structural biology and therapeutic protein engineering. Here, we describe a short trimerization motif (rFd1303) derived from the Reoviridae family reovirus σ1 protein. Compared with the widely used T4-Foldon, the rFd1303 increased recombinant protein yields. The rFd1303-fused immunogens of SARS-CoV-2 spike and influenza hemagglutinin elicited antibody responses comparable to T4-Foldon-fused controls in mice. Using this tag, we engineered a trimeric ACE2-Ig fusion protein (TriACE2-Ig) that remained stable after 30 days at room temperature and neutralized a broad range of ACE2-utilizing sarbecoviruses, including 19 SARS-CoV-2 variants, SARS-CoV, and pangolin coronaviruses GD and GX, with higher potency than monomeric ACE2-Ig. In the hamster model challenged with various SARS-CoV-2 variants, our data demonstrated that intranasal TriACE2-Ig administration markedly reduced viral loads, virus-induced body-weight loss, lung pathology, and decreased within-cage virus transmission. These findings highlight rFd1303 as a versatile trimerization platform for vaccine and therapeutic protein development.

PMID 42928093
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PubMedJournal of the International AIDS Society2026-10-26

Impact of HIV Pre-Exposure Prophylaxis on HIV Incidence and Hepatitis B Outcomes Among Sex Workers Living With Hepatitis B: A Modelling Analysis in Côte D'Ivoire.

Mohareb Amir M AM, Kim Arthur Y AY, Kouamé Menan Gérard MG, Nouaman Marcellin M et al.

Nearly 10% of sex workers in sub-Saharan Africa live with chronic hepatitis B virus (HBV). HIV pre-exposure prophylaxis (PrEP) using tenofovir/emtricitabine (TDF/FTC) has not been studied in this population, possibly due to concerns of hepatitis flares following TDF/FTC cessation. Using a microsimulation model of HIV and HBV disease and data from 2016 to 2024, we compared the clinical impact of TDF/FTC as PrEP versus no TDF/FTC among women who sell sex with HBV in Côte d'Ivoire. We incorporated the anti-HBV effects of TDF/FTC and the increased probability of hepatitis flares and HBV surface antigen (HBsAg) loss following TDF/FTC cessation. We estimated input parameters from published literature: HIV incidence (1.9-3.0 per 100 person-years), PrEP adherence (55%), disengagement from PrEP care (4% per month for the first 12 months, then 12.5% per month), hepatitis flare incidence (2.0-4.0 per 100 person-years) and rate of HBsAg loss (1.0 per 100 person-years), which both increase following TDF/FTC cessation. Model outcomes included cumulative HIV incidence, average hepatitis flares, HBsAg loss and survival over 2, 5 and 10 years. We conducted sensitivity analyses varying HIV incidence, PrEP adherence, disengagement from PrEP care and hepatitis flare rate. Compared with no TDF/FTC, TDF/FTC would reduce cumulative HIV incidence: 4.1% versus 5.6% at 2 years and 10.1% versus 12.7% at 5 years. TDF/FTC would result in more hepatitis flares (mean 0.76 vs. 0.19 per person) and more HBsAg loss (8.4% vs. 5.7%) than no TDF/FTC after 5 years. Two- and five-year survival would be similar between the two strategies, and TDF/FTC would improve survival over longer horizons. Improving adherence and reducing disengagement from care would increase clinical benefits. Even with high disengagement from care and high risk of hepatitis flares, TDF/FTC would reduce HIV acquisition and improve overall long-term survival. Women who sell sex with HBV in Côte d'Ivoire would benefit from TDF/FTC as PrEP to avoid HIV acquisition. The increased risk of hepatitis flares, while challenging to manage in resource-limited settings, would be outweighed by the benefits of HIV prevention. Efforts should be made to scale up PrEP in sex workers, including women with chronic HBV.

PMID 42929139
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PubMedJournal of medical virology2026-10-26

Development and Validation of a Nomogram to Predict Recompensation in Patients With HBV-Related Acute-on-Chronic Liver Failure: A Multicenter Retrospective Study.

Zhang Junchao J, Lin Yehong Y, Zhu Yueyong Y

Limited studies have investigated the predictors of hepatic recompensation in patients with hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF). Establishing a clinically applicable predictive model for recompensation in ACLF patients is of critical importance. A total of 304 HBV-ACLF patients were included in the study, 169 patients as training cohort and 135 patients as validation cohort. In the training cohort, 72 patients (42.6%) achieved recompensation within the first year following an ACLF episode, whereas 87 patients (64.4%) in the validation cohort achieved recompensation during the same period. Age, alpha-fetoprotein, total bilirubin, white blood cell count, hepatic encephalopathy, and gastrointestinal bleeding were selected for inclusion in the model. The nomogram demonstrated excellent discriminative ability, with an area under the curve (AUC) of 0.842 (95% CI: 0.784-0.900) in the training cohort and 0.855 (95% CI: 0.785-0.926) in the validation cohort. Calibration curves showed strong agreement between predicted and observed recompensation rates. DCA further confirmed the model's clinical utility for decision-making. This model demonstrated superior predictive performance compared to the MELD score, MELD-Na score, and MELD 3.0 score. The developed nomogram provides an accurate and clinically applicable tool for predicting recompensation likelihood, enhancing personalized management of HBV-ACLF patients.

PMID 42929752
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PubMedInternational journal of fertility & sterility2026-10-26

Viral Infections and Ovarian Reserve: Mechanistic Insights into Ovarian Aging- A Review.

Haratian Kaveh K, Borjian Boroujeni Parnaz P, Zarei Moradi Shabnam S, Mohseni Meybodi Anahita A

Ovarian aging, marked by the progressive loss of follicular reserve and decline in oocyte quality, is a principal determinant of female reproductive lifespan. While genetic and environmental factors are well-established contributors, viral infections, including both DNA and RNA viruses, are increasingly recognized as significant extrinsic modulators of ovarian function. This review synthesizes current evidence on the mechanisms and clinical outcomes by which key viral pathogens, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), hepatitis B virus (HBV), human immunodeficiency virus (HIV), cytomegalovirus (CMV), human papillomavirus (HPV), mumps virus, herpes simplex virus (HSV), and rubella virus, affect ovarian aging and reserve. The discussion highlights those viral infections can impact ovarian function through inflammation, cytopathic effects, oxidative stress, and immune-mediated mechanisms, although the magnitude and clinical relevance vary. Current evidence for viruses such as SARS-CoV-2 and HBV is limited and inconsistent, highlighting the need for individualized assessment when considering fertility interventions. Further longitudinal and mechanistic studies are essential to clarify long-term reproductive outcomes and to guide evidence-based fertility counseling.

PMID 42929014
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PubMedCancer discovery2026-10-26

First mRNA Cancer Vaccine Succeeds in Phase III Trial.

Adding the mRNA-based individualized neoantigen vaccine intismeran autogene to the PD-1 inhibitor pembrolizumab following surgery for melanoma reduced the risk of disease recurrence or death by 42%, according to the results of the phase III INTerpath-0001 trial. The data were presented at the ESMO Congress 2026, held October 23-27, in Madrid, Spain.

PMID 42929716
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