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freeze-dried live attenuated hepatitis A vaccine

✓ Approved

Changchun Institute · Vaccine · Vaccine

What is freeze-dried live attenuated hepatitis A vaccine?

freeze-dried live attenuated hepatitis A vaccine is a vaccine developed by Changchun Institute. It is approved for therapeutic indications via injectable (others).

Drug Profile

CompanyChangchun Institute
Drug ClassVaccine, Large Molecules
RouteInjectable (Others)
StatusApproved

Therapeutic Indications

freeze-dried live attenuated hepatitis A vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresAntiviral prophylaxis✓ Approved

Related Research Articles

PubMedFrontiers in microbiology2026-10-15

Biosorption of synthetic dyes by live and dried marine diatom Phaeodactylum tricornutum and freshwater diatom Navicula cryptocephala var. veneta.

Howard Ceaira C, Rahman Tahira Tasneem TT, Li Mingyue M, Hortin Kesler K et al.

Diatom biomass has emerged as a promising biosorbent for removing dye pollutants from dye-bearing wastewater due to its low cost, sustainability, and abundant surface functional groups. Despite interest in algal biosorption, limited studies have compared live and dried biomass across different diatom species. The relative importance of species identity, biomass state, and operating conditions therefore remains unquantified. This study addresses these gaps by investigating the adsorption of three cationic dyes: crystal violet (CV), malachite green (MG), and basic fuchsin (BF), by two diatom species, Phaeodactylum tricornutum and Navicula cryptocephala var. veneta. The effects of dye concentration, pH, temperature, and biomass state were systematically evaluated. For dry cells, adsorption capacity increased with dye concentration due to enhanced mass transfer driving force. Maximum removal efficiencies by P. tricornutum reached 91.3% for CV, 88.6% for MG, and 85.9% for BF, corresponding to equilibrium adsorption capacities of 16.7, 36.6, and 26.6 mg/g, respectively, while N. veneta showed lower removal (13.8, 31.8, and 20.3 mg/g) and earlier saturation at higher concentrations. Neutral pH yielded optimal performance. However, MG and BF exhibited strong pH dependence because of surface charge effects and dye ionization, while CV was relatively insensitive to pH. Temperature effects were strongest for MG, smaller but significant for BF, and not significant for CV. Species and biomass state were the dominant factors controlling adsorption. P. tricornutum consistently outperformed N. veneta across all dyes and conditions tested. Dried biomass achieved significantly higher removal (CV = 70% to 91%, MG = 75% to 87%, BF = 61% to 84%) than live biomass (CV = 45% to 85%, MG = 70% to 82%, BF = 49% to 79%). This may be due to the drying process removing extracellular polymeric substances and membrane barriers, exposing reactive functional groups (e.g., -COO- and Si-O-) and promoting surface-controlled electrostatic interactions. Isotherm analysis indicated adsorption onto an energetically heterogeneous surface. The concentration range examined did not reach saturation in all systems, so maximum adsorption capacities are reported only where the data constrain them. These findings establish biomass state and species identity as the dominant controls on dye biosorption under the conditions tested. This work highlights dried marine and freshwater diatoms as sustainable biosorbents for broad-spectrum dye remediation.

PubMedFrontiers in immunology2026-10-15

Fresh ginseng-derived vesicle-like nanoparticles protect against intestinal barrier injury in inflammatory bowel disease via the miR-29a-5p/TLR4 axis.

Tang Xiaojuan X, Ren Yuan Y, He Min M, Lv Yuan Y et al.

Inflammatory bowel disease (IBD) remains therapeutically challenging, and disruption of the intestinal epithelial barrier constitutes a key pathogenic event. Ginseng-derived vesicle-like nanoparticles (GDNPs) protect against intestinal barrier injury in IBD; however, the effects of ginseng processing on nanoparticle characteristics and biological activity remain insufficiently understood. The protective effect of fresh and dried ginseng extract were compared in IBD model. GDNPs were isolated from fresh and dried ginseng by differential centrifugation and sucrose density-gradient ultracentrifugation, and characterized for morphology, particle size, and relative purity. Their effects on intestinal epithelial cell viability and permeability were compared. In vitro, inflamed NCM460 and RAW264.7 cells were treated with fresh GDNPs; tight junction protein expression and TLR4/STAT3 signaling were assessed by western blotting, and cytokine and miRNA (miR-29a-5p, miR-125b-5p, miR-21-5p) levels were measured by RT-qPCR. Trans-epithelial electrical resistance (TEER) was measured in epithelial cells overexpressing miR-29a-5p, and tight junction protein and TLR4 expression were examined after miR-29a-5p knockdown; direct targeting of TLR4 by miR-29a-5p was confirmed by dual-luciferase reporter assay. Intestinal epithelial cells were also exposed to conditioned medium from fresh GDNP-treated macrophages to assess tight junction protein and miR-29a-5p expression. In vivo, a dextran sulfate sodium (DSS)-induced murine colitis model was used to evaluate the preventive protective effects of low- or high-dose fresh GDNPs, and body weight, disease activity index (DAI), colon length, histopathology, macrophage polarization, tight junction protein expression, and inflammatory cytokine and miR-29a-5p levels were evaluated. Both fresh and dried ginseng extracts alleviated DSS-induced intestinal injury, with fresh ginseng extract showing stronger protective effects in several pathological and inflammatory parameters. Fresh and dried GDNPs showed comparable spherical morphology and particle-to-protein ratios, but fresh GDNPs were more susceptible to Triton X-100-induced lysis, indicating a higher proportion of intact vesicles. Fresh GDNPs promoted intestinal epithelial cell viability, whereas dried GDNPs at the same concentration had no significant effect, and fresh GDNPs conferred stronger protection against epithelial permeability disruption. In inflamed epithelial and macrophage models, fresh GDNPs suppressed TLR4/STAT3 signaling and pro-inflammatory cytokines (IL-6, IL-1β, TNF-α) while restoring tight junction proteins (Occludin, Claudin-1) and miR-29a-5p expression. Mechanistically, fresh GDNPs preserved epithelial barrier integrity by upregulating miR-29a-5p, which directly targeted and suppressed TLR4, and by reprogramming the macrophage inflammatory secretome. In DSS-induced colitis, fresh GDNPs attenuated body weight loss, DAI scores, and colon shortening; reduced M1 macrophage polarization; preserved tight junction protein expression; and restored miR-29a-5p expression in colon tissue. Fresh and dried ginseng-derived GDNPs exhibited differential epithelial protective effects in vitro. Fresh ginseng-derived GDNPs protected intestinal barrier integrity through the miR-29a-5p/TLR4 axis and macrophage-epithelial crosstalk.

PubMedFrontiers in pharmacology2026-10-15

Four-week supplementation with a blackcurrant formulation enhances cognitive performance, reduces mental fatigue and modulates peripheral monoamine metabolism in older adults: a randomized, double-blind, placebo-controlled, crossover study.

Lomiwes Dominic D, Günther Catrin S CS, Kanon Alexander P AP, Lo Kim K et al.

Age-related cognitive decline is an increasing concern in older adults. While blackcurrants (Ribes nigrum) have shown promise in improving cognitive outcomes in younger adults, their efficacy in supporting cognitive function in older adults is largely unexplored. In this randomized, placebo-controlled, double-blinded crossover study of healthy older adults (62 ± 1 years), 26 of the 30 participants enrolled completed the study per protocol. Participants consumed either a placebo or a flavonoid-rich blackcurrant formula (BCF, 7.8 mg anthocyanins/kg body weight freeze-dried blackcurrant, 200 mg L-theanine, and 100 mg pine bark extract) in a beverage format daily for 4 weeks, with interventions separated by a two-week washout period. For each intervention, cognitive and mood outcomes were assessed following a single dose (acute) and after 4 weeks' supplementation. Platelet MAO-B activity, circulating neurotransmitter concentrations, and anthocyanin, L-theanine and sarmentosin bioavailability were measured from venous blood samples drawn at baseline, 1 h, 2.4 h and 4 wk after intervention supplementation. A significant reduction in Rapid Visual Information Processing (RVIP) false alarms (p = 0.022) and a strong trend in reduced mental fatigue (p = 0.046, q = 0.067) were measured following 4 weeks of BCF supplementation. Reduction in biomarkers of MAO activity were measured following acute supplementation with BCF, but not placebo, with significant treatment × time interactions (q < 0.01) for platelet MAO-B activity, plasma 5-hydroxyindoleacetic acid and 3,5-dihydroxyphenylglycine concentrations. These changes corresponded with significant reductions (q < 0.05) in circulating neurotransmitter metabolites xanthurenic acid, 3-methoxy-4-hydroxyphenylglycol and vanillylmandelic acid. Findings from this study indicate that 4 weeks of BCF supplementation sustained attention in healthy older adults, extending evidence for BCF-related cognitive benefits across both younger and older populations. https://anzctr.org.au/, identifier: ACTRN12621001590853.

PubMedFrontiers in immunology2026-10-15

Case report: Maternal engraftment of T-cells in a patient with Severe Combined Immunodeficiency due to DCLRE1C pathogenic variant - diagnostic and treatment challenges.

Peiseniece Evija E, Rozevska Marija M, Arnite Viktorija V, Rascon Jelena J et al.

Severe combined immunodeficiency (SCID) is a rare but serious congenital condition caused by genetic defects that severely impair the development and function of T cells, B cells, and natural killer (NK) cells. Without early diagnosis and immune system reconstitution, SCID is usually fatal in infancy. The condition requires prompt recognition and hematopoietic stem cell transplantation (HSCT) to restore immune function. This report describes the first genetically confirmed case of SCID in Latvia - caused by a DCLRE1C gene pathogenic variant and diagnosed prior to the implementation of national newborn screening for SCID - complicated by disseminated tuberculosis following Bacillus Calmette-Guérin (BCG) vaccination. The male infant was born after an uneventful pregnancy to healthy parents with no known genetic disorders. The patient experienced recurrent bacterial respiratory infections and received the first scheduled vaccination, the BCG vaccine, at 2 months of age, later than recommended in the national immunization schedule because of parental hesitancy related to concerns about vaccine safety. Shortly after receiving the BCG vaccine, the infant developed erythroderma and a maculopapular rash, followed by pneumonia, acute bronchiolitis, and a bacterial skin infection at three months of age. Immunological evaluation revealed an atypical pattern for SCID, with CD3+ T cells at 53% (abs. 764/μL) and CD4+ T cells at 52% (abs. 748/μL), but a profound deficiency of CD8+ T cells (0.79%, abs. 11/μL). In our case, genetic analysis identified a homozygous pathogenic variant in the DCLRE1C gene. The presence of an XX cell line suggested maternal T-cell engraftment. The patient underwent HSCT; however, post-transplant disseminated tuberculosis required antituberculosis therapy and significantly affected the outcome. This case underscores the importance of early diagnosis and, specifically, early antimycobacterial prophylaxis in SCID: although the diagnosis was genetically confirmed at 4 months of age, prophylactic antimycobacterial treatment was not started until disseminated BCG disease was identified 3.5 months later, at 7.5 months of age, and this delay was followed by prolonged multidrug antimycobacterial therapy and a complicated post-transplant course. This highlights the risks of administering live vaccines before immune status is confirmed and reinforces the critical role of newborn screening programs for SCID, which Latvia began implementing on April 1, 2023.

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.

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.

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