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influenza vaccine (GC Flu quadrivalent / GCFlu quadrivalent / GC3110A)

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Medigen Vaccines Biologics · Vaccine · Vaccine

What is influenza vaccine?

influenza vaccine is a vaccine developed by Medigen Vaccines Biologics. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesGC Flu quadrivalent, GCFlu quadrivalent, GC3110A
CompanyMedigen Vaccines Biologics
Drug ClassVaccine, Large Molecules
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved

Related Research Articles

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.

PubMedInfectious diseases and therapy2026-10-15

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

Moldt Brian B, Ubeda Rafael A RA, Murray Alexander V AV, Tima Giresse G et al.

Influenza vaccines targeting both hemagglutinin (HA) and neuraminidase (NA) might offer broader protection than current vaccines, which primarily target HA. This randomized phase 2 study evaluated the immunogenicity and safety of an investigational mRNA-based trivalent seasonal influenza vaccine encoding HA and NA from A/H1N1, A/H3N2, and B/Victoria (FLUm3HA-3NA). Participants aged 18-64 years (younger adults) or 65-85 years (older adults) received one of several mRNA vaccine formulations-each containing different influenza A and B HA mRNA doses-or an age-appropriate licensed seasonal influenza vaccine as a comparator. Four formulations per age cohort were tested in part 1 of the study, and one formulation per age cohort in part 2. Day-29 hemagglutination inhibition (HI) and NA inhibition (NI) responses were assessed as primary and secondary endpoints, respectively, safety/reactogenicity as the secondary, and virus neutralization as the tertiary endpoint. A total of 250 younger and 260 older adults were vaccinated in part 1; 161 and 162, respectively, in part 2. All FLUm3HA-3NA formulations induced HI, NI, and neutralizing responses above baseline. In part 1, HI responses against A/H1N1 and A/H3N2 were similar or higher after FLUm3HA-3NA than after comparator vaccination in both age groups. For B/Victoria, HI responses were lower or similar versus comparator vaccination in younger adults and similar or higher in older adults. In part 2, HI responses were similar or higher with FLUm3HA-3NA versus comparators for A/H1N1 and A/H3N2, and lower for B/Victoria in both age groups. In both study parts and both age groups, NI titers were higher for all three strains with FLUm3HA-3NA versus comparators, and neutralizing titers were similar or higher for A/H1N1 and A/H3N2 and similar for B/Victoria. No safety concerns were identified. FLUm3HA-3NA induced HI, NI, and neutralizing responses, with an acceptable safety profile. The results support further development, including optimization of the influenza B HI response. ClinicalTrials.gov: NCT06431607.

PubMedEpidemiology and infection2026-10-15

Establishing influenza epidemic thresholds and intensity levels in Türkiye using the moving epidemic method and assessing concordance with WHO transmission zones: A sentinel surveillance analysis of ten seasons, 2013-2025.

Ontas Eray E

The Moving Epidemic Method (MEM) is the ECDC/WHO-Europe-endorsed approach for establishing influenza epidemic thresholds and intensity levels, yet no positivity-based MEM analysis exists for Türkiye or any country in the WHO Western Asia transmission zone. Weekly influenza positivity rates from FluNet sentinel surveillance were analysed for ten of twelve seasons (2013/2014-2024/2025, excluding two COVID-19 pandemic seasons) using the mem R package with cross-validated optimized slope parameter, and Türkiye's average epidemic curve and thresholds were compared with the Western Asia (excluding Türkiye) and South West Europe zones using Lin's concordance correlation coefficient (CCC), root mean square deviation (RMSD) and complementary correlation metrics. The epidemic threshold was 10.59% positivity, with intensity thresholds at 42.56% (medium), 60.92% (high), and 71.38% (very high); cross-validated sensitivity was 0.77, specificity 0.88, and Matthews correlation coefficient 0.65. Türkiye's average curve showed higher concordance with Western Asia (CCC=0.890; RMSD=4.22 percentage points) than South West Europe (CCC=0.672; RMSD=12.48) despite similar Pearson correlations (0.922 vs. 0.939), and the Western Asia epidemic threshold (11.50%) closely matched Türkiye's. These first operational MEM thresholds for Türkiye and the first positivity-based thresholds for the Western Asia zone confirm alignment with the current WHO transmission zone classification and support integration into routine surveillance.

PubMedAnimal bioscience2026-10-15

Multi-trait GWAS and comparative genomics identify candidate genes associated with egg weight and yolk lipid deposition in chicken.

Ji Qianyun Q, Wang Xiao X, Shi Jiajia J, Han Linnan L et al.

Yolk lipids support embryonic and post-hatch development in poultry, while egg weight serves as a crucial selection trait regulated by polygenes. Understanding the genetic mechanisms underlying egg weight and yolk weight helps improve chicken breeding. This research aimed to explore key genomic regions and candidate genes potentially associated with these traits in indigenous chickens, to provide theoretical basis and genetic resources for genomic selection and precision breeding. Phenotypic and genetic correlation analyses were performed on indigenous chicken populations. Single-trait and multi-trait genome-wide association studies (GWAS) were used to screen trait-related SNPs. Selective sweep and runs of homozygosity (ROH) island analyses across chicken breeds were implemented to verify candidate regions. Upstream transcription factors and signaling pathways of candidate genes were further investigated for molecular mechanism validation. Egg weight was strongly positively correlated with yolk weight in indigenous chickens. Integrated analyses of GWAS, MTAG, ROH, and selection signatures highlighted FASN and FAR1 as candidate genes potentially associated with egg and yolk weight. Functional verification demonstrated that transcription factor Sp1 activates the expression of FASN. This interaction promotes lipid metabolism and lipid droplet synthesis in chicken hepatocytes, suggesting a potential regulatory mechanism that may contribute to egg weight and yolk weight variation. This study highlights candidate loci and genes associated with egg and yolk weight in indigenous chickens and provides in vitro evidence supporting the involvement of the Sp1-FASN axis in hepatic lipid metabolism. These findings provide insights into the potential molecular mechanisms underlying yolk lipid deposition and provide candidate loci for further validation in genetic improvement of egg weight.

PubMedFrontiers in immunology2026-10-15

Myeloid cell expression of the VDR and parathyroid hormone control the host response to influenza infection in mice.

Tang Mengzhu M, Froelich Nicole E NE, Hanna Nicholas J NJ, Weaver Veronika C VC et al.

Respiratory infections caused by seasonal influenza viruses remain a major global health burden. Vitamin D receptor (VDR) signaling regulates immune responses, but the role of the VDR and its interaction with parathyroid hormone (PTH) in host resistance to H1N1 influenza infection is not understood. Global VDR knockout (KO) mice, or myeloid (M) deletion of the VDR (M-VDR KO) and the respective wildtype (WT) littermates were infected with H1N1 influenza virus. Additional experiments treated WT mice with intermittent PTH or vehicle and then infected them with a H1N1 influenza A virus. Disease severity, mortality, viral burden and clearance, lung pathology, and inflammatory cytokine responses were evaluated. H1N1 influenza infection of WT mice resulted in non-lethal disease, whereas VDR KO mice had 21% mortality, delayed viral clearance, more severe symptoms and lung pathology. The increased severity of respiratory disease was accompanied by higher type I and II interferon responses in the lungs. M-VDR KO mice had increased disease severity and delayed viral clearance compared to WT littermates. PTH-treated WT mice had increased clinical scores, influenza M gene, and cytokine responses compared to vehicle treated WT mice. The work describes a novel paradigm in which the vitamin D-PTH axis governs host resistance to influenza virus disease by controlling the amount of inflammation and the amount of virus in the lung. In addition, the data suggest that VDR expression in myeloid cells is critical for controlling the early innate immune response to influenza viruses.

PubMedDrug and chemical toxicology2026-10-15

In ovo exposure to triphenyltin hydroxide induces genotoxicity, cytotoxicity and developmental toxicity in chick embryos, Gallus gallus domesticus.

Paul Dipsanu D, Nath Barbhuiya Sweety S, Giri Sarbani S, Barhoi Dharmeswar D

Triphenyltin hydroxide (TPTH) is a widely used agricultural fungicide and environmental pollutant well known for its potent toxicological potential. Despite this, its embryotoxic effects remain unexplored in avian models. This study presents a novel evaluation of TPTH's acute toxicity, genotoxicity, cytotoxicity, teratogenic potential, and enzymatic and tissue architectural potential using the in ovo chick embryo model. Fertilized chicken eggs were exposed to varying TPTH concentrations that further revealed a time-dependent median lethal dose (LD50) decline from 547.37 µg/egg at 24 h to 395.74 µg/egg at 96 h. Later, evaluations using 1%, 5%, and 10% of the 96 h LD50 demonstrated profound subcellular damage. The Hen's egg test for micronucleus (HET-MN) assay showed a significant dose-dependent induction of micronuclei, confirming genomic instability. Additionally, a reduced polychromatic to normochromatic erythrocyte (PCE/NCE) ratio indicated severe cytotoxicity and suppressed erythropoiesis. Morphometric assessments revealed teratogenic alterations, including heart tube failure, microcephaly, cranial edema, microphthalmia, localized hemorrhaging, and concentration-dependent growth retardation in body length, eye diameter, and limb elongation. Biochemical assessments revealed that TPTH triggers severe oxidative stress. This was supported by significant dose-dependent reductions in superoxide dismutase, catalase, and glutathione across major organs, alongside increased lipid peroxidation in the brain. Histopathological analysis also revealed severe toxicity. These findings validated that TPTH induces potent developmental toxicity through a cascade of genotoxic, cellular, enzymatic damage, and structural alterations, highlighting its extreme embryotoxic risks to avian populations and associated ecosystems.

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