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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

PubMedFrontiers in cellular and infection microbiology2026-10-15

Immunogenicity and protective efficacy of recombinant BCG expressing a multi-epitope vaccine against mycobacterium tuberculosis.

Zhang Xuan-Ji XJ, Luo Jia-Rui JR, Tian Ting-Ting TT, Shi Juan J et al.

Mycobacterium tuberculosis (Mtb) infects approximately one-quarter of the global population, of whom 5%-10% develop active tuberculosis (TB). Although Bacillus Calmette-Guérin (BCG) remains the cornerstone vaccine against severe infant TB, its efficacy in adults is limited, underscoring the need for novel TB vaccines. This study aimed to design a multi-epitope vaccine, tMEV, and validate its protective potential through bioinformatic prediction and in vivo experiments. tMEV was constructed from dominant T- and B-cell epitopes derived from Mtb ESAT-6, PE35, PPE38, and PE4 proteins, fused with an adjuvant. Its vaccine candidacy was assessed via physicochemical and solubility profiling, secondary and tertiary structure modeling, TLR-4 molecular docking, molecular dynamics simulation, and immune simulation. The tMEV coding sequence was cloned into pMV361 and transformed into BCG to generate recombinant BCG (rBCG-tMEV). Immunogenicity, antigenicity, and protective efficacy were evaluated in mouse immunization and Mtb challenge models. tMEV exhibited favorable vaccine-like properties in silico. In mice, both tMEV and rBCG-tMEV induced Mtb-specific immune responses. Compared with PBS, tMEV significantly enhanced cellular and humoral immunity with a Th2-biased profile. Relative to conventional BCG, rBCG-tMEV elicited a superior mixed Th1-Th2 response and higher antigen-specific immunity, accompanied by increased secretion of IFN-γ, IL-2, TNF-α, granzyme B, and perforin. Moreover, rBCG-tMEV markedly reduced bacterial loads in the lungs and spleens of Mtb-infected mice, conferring partial protection. These findings demonstrate that tMEV and rBCG-tMEV possess robust immunogenicity and protective potential against Mtb, representing promising novel TB vaccine candidates and providing a rationale for future vaccine development and optimization.

PMID 42876677
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PubMedJournal of viral hepatitis2026-10-15

Global Underutilization of Antiviral Therapy and Survival Outcomes in Hepatitis B Virus-Related Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis of 78 Studies and 68,243 Patients.

Kudaravalli Sahith S, Yan Taotao T, Tseng Cheng-Hao CH, Hsu Yao-Chun YC et al.

Antiviral therapy with nucleos(t)ide analogues is recommended for patients with viremic hepatitis B virus (HBV)-related cirrhosis regardless of levels of viremia or liver enzymes. However, hepatocellular carcinoma (HCC) is not an antiviral treatment criterion in the U.S. HBV treatment guidelines, though prior studies have reported improved survival with antiviral treatment in HBV-related HCC. To inform guidelines, we estimated antiviral treatment rates and their association with survival and HCC recurrence rates in HBV-related HCC. We conducted a systematic review and meta-analysis of studies published between 2006 and 2024 that reported antiviral treatment, survival, and/or HCC recurrence rates in adults with HBV-related HCC, following PRISMA guidelines. Random-effects models pooled study estimates. Of the initial 4556 studies, 178 underwent full-text review, and 78 (68,243 patients) were analysed. The pooled antiviral treatment rate (52 studies, 41,345 patients) was 53.1%. In studies reporting pre-HCC antiviral initiation, 17.2% of HBV-related HCC patients received therapy before diagnosis. Treated (vs untreated) patients had higher 3- and 5-year OS (80.4% vs. 59.2% and 72.1% vs. 46.8%, both p < 0.01). Five-year OS was 78.0% vs. 56.4% in inactive HCC (p < 0.01) and 48.2% vs. 22.6% in active HCC (p = 0.14). Antiviral therapy remained independently associated with improved 5-year OS in multivariable meta-regression. There was no significant difference in HCC recurrence rates. Antiviral therapy is associated with improved long-term survival but remains underutilized in HBV-related HCC. These findings highlight a critical gap in care and underscore the need for earlier and more consistent antiviral initiation in patients with HBV-related HCC.

PMID 42876044
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PubMedJournal of digestive diseases2026-10-15

Single Jaundice in Cirrhosis: A Neglected Acute Decompensation of Acute-on-Chronic Liver Failure and Mortality.

Zhang Xin X, Wang Xian Bo XB, Zheng Xin X, Tan Wen Ting WT et al.

To compare the risk of acute-on-chronic liver failure (ACLF) and short-term outcomes among cirrhotic patients with single jaundice, acute decompensation (AD) (including ascites, variceal bleeding, hepatic encephalopathy, and/or bacterial infection), and non-AD non-jaundice. We analyzed cirrhotic inpatients without obstructive jaundice enrolled from two large multicenter prospective cohorts. Patients were divided at admission into classical AD, single jaundice, or non-AD non-jaundice groups. Baseline characteristics, ACLF development, and short-term outcomes were compared between groups. Among 2645 cirrhotic patients, classical AD, single jaundice, and non-AD non-jaundice were observed in 2163 (81.78%), 267 (10.09%), and 215 (8.13%), respectively. The 90-day liver transplant (LT)-free mortality was comparable between single jaundice patients and classical AD patients (15.09% vs. 17.81%, p = 0.266), but significantly higher than non-AD non-jaundice patients (2.45%; p < 0.01). The prevalence of ACLF (16.10% vs. 16.09%, p = 1.000) and pre-ACLF (9.36% vs. 6.43%, p = 0.094) were comparable between the single jaundice and classical AD groups. Intrahepatic precipitants, particularly hepatitis B flare with hepatitis B virus (HBV) reactivation (odds ratio [OR] 2.69; p = 0.002), spontaneous hepatitis B flare with high HBV-DNA load (OR 23.75; p < 0.001), superimposed hepatitis A/E virus infection on HBV infection (OR 13.40; p < 0.001) and hepatotoxic drug usage (OR 3.64; p < 0.001) were associated with single jaundice. Cirrhotic inpatients with single jaundice show comparably high short-term mortality and ACLF risk to those with classical AD. Single jaundice shall be considered as an AD event and is predominantly triggered by intrahepatic insults, warranting surveillance equivalent to classical AD and prioritized management of the precipitants.

PMID 42876334
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PubMedMicrobial cell factories2026-10-15

RNA thermometers as temperature-dependent tools for enhanced recombinant protein production in precision fermentation.

Peternell Christina C, Noll Philipp P, Henkel Marius M

Precision fermentation is a key technology for the future sustainable production of food proteins, bulk ingredients, and high-value recombinant products. However, process efficiency is often limited by the coupling of biomass formation and recombinant protein synthesis, leading to substantial carbon losses into non-recyclable biomass. Particularly for cost-sensitive bulk products such as food proteins, economically viable production requires highly efficient and dynamically controllable bioprocesses. RNA thermometers (RNATs) offer a promising inducer-free strategy for temperature-dependent control of recombinant protein production and dynamic bioprocess regulation, with the potential to improve carbon efficiency and product yields. In this study, a fluorescent reporter protein (EmGFP) under the control of a fourU (4U) RNA thermometer was evaluated in E. coli BL21 across a temperature range of 25-40 °C. Temperature-dependent regulation enabled maximal recombinant protein production at 35 °C, resulting in a 2.6-fold higher specific productivity compared to the derepressed control. The strongest RNAT-mediated regulatory effect was observed at 35.5 °C, highlighting the relevance of precise temperature control for recombinant protein production. Evaluation of altered carbon partitioning revealed a substantially increased carbon allocation toward product formation, while carbon partitioning into biomass and CO2 remained largely unchanged. Furthermore, the product-per-acetate yield increased more than threefold at induction temperature, indicating controllable carbon partitioning and reveals potential for decoupling approaches of biomass formation from recombinant protein production. This study demonstrates the successful implementation of an RNAT-controlled recombinant expression system enabling temperature-dependent regulation of protein production in E. coli. Quantitative analysis revealed controllable carbon partitioning toward recombinant protein synthesis and defined target temperatures for future process induction and switching. In contrast to conventional inducer-based systems, RNAT-mediated regulation enables dynamic control without chemical additives, supporting more resource-efficient bioprocess operation. However, fully exploiting RNAT-based process control will require advanced model-based strategies integrating temperature and feeding regimes, particularly for cost-sensitive precision fermentation processes such as food protein production. Overall, RNATs represent promising molecular control elements for future high-efficiency precision fermentation processes.

PMID 42875774
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PubMedAdvanced materials (Deerfield Beach, Fla.)2026-10-15

Correction to "Screening Natural Cholesterol Analogs to Assemble Self-Adjuvant Lipid Nanoparticles for Antigens Tagging Guided Therapeutic Tumor Vaccine".

PMID 42876174
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PubMedInfectious diseases and therapy2026-10-15

A Phase 1/2 Trial Evaluating the Safety and Immunogenicity of an mRNA-based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase.

De Coster Ilse I, Cardona Jose F JF, Ferguson Murdo M, Leroux-Roels Isabel I et al.

Hemagglutinin (HA) is the principal immunologic target of most licensed seasonal influenza vaccines. Targeting both HA and neuraminidase (NA) might improve vaccine effectiveness. This randomized phase 1/2 study evaluated an investigational mRNA-based quadrivalent seasonal influenza vaccine, encoding HA and NA of A/H1N1, A/H3N2, B/Victoria, and B/Yamagata (FLUm4HA-4NA). In phase 1, adults aged 18-50 years received either one of twelve mRNA vaccine formulations of varying HA-only or HA and NA mRNA doses, or a licensed quadrivalent seasonal influenza comparator. In phase 2, participants aged 18-64 years (younger adults) and 65-85 years (older adults) received FLUm4HA-4NA (three groups per age category, with different HA/NA mRNA doses) or age-appropriate licensed quadrivalent comparator. Primary endpoints were safety/reactogenicity, and hemagglutination inhibition [HI] and NA inhibition [NI] responses against the four seasonal strains at day 29. Cross-reactive HI/NI responses against drifted strains, virus neutralization, and HA-/NA-specific cell-mediated immunity were evaluated in phase 2 as tertiary objectives. A total of 293 participants (21-25 per group) were vaccinated in phase 1, 480 younger (108-137 per group) and 483 older adults (117-125 per group) in phase 2. Solicited events were more frequent with FLUm4HA-4NA than comparators and were mostly short-lived and mild or moderate. No deaths or vaccine-related serious adverse events were reported. Post-vaccination HI and neutralizing titers in the FLUm4HA-4NA groups were similar or higher for the A strains and lower for the B strains versus comparators. NI responses exceeded those of comparators for all four strains. HI and NI titers against evaluated drifted A strains were similar or higher after FLUm4HA-4NA than after comparator vaccination. HA-specific CD4+ and CD8+ T-cell responses were generally higher after FLUm4HA-4NA than comparator vaccination. FLUm4HA-4NA showed an acceptable safety profile and humoral and cellular immunogenicity in the study population, supporting further development and formulation optimization to improve influenza B HI responses. ClinicalTrials.gov: NCT05823974; euclinicaltrials.eu: 2022-502308-66-00.

PMID 42875683
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