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influenza vaccine (Ultravac / Ultravak)

✓ Approved

Microgen · 疫苗 · 疫苗

什么是 influenza vaccine？

influenza vaccine 是一种疫苗，由Microgen研发。该药已获批，用于治疗相关适应症，给药途径：Inhaled。

药物档案

商品名Ultravac, Ultravak
公司Microgen
药物类别疫苗, 大分子
给药途径Inhaled
状态Approved
来源： ClinicalTrials.gov, Microgen

相关研究文献

PubMedVaccines2026-07-27

Strain Matching of Seasonal Influenza Vaccines and Emergence of Neuraminidase Inhibitor Resistance in China from 2015 to 2025.

He Peiqing P, Luo Junhao J, Pu Siyu S, Cui Simin S et al.

Background: Influenza remains a major global public health threat, and vaccination is one of the most effective preventive measures. However, frequent antigenic drift and occasional antigenic shift, along with the lead time required for vaccine development and regional differences in the evolution of circulating strains, may lead to mismatches between WHO-recommended vaccine strains and circulating viruses. In addition, antiviral resistance further complicates precise influenza prevention and control. Objectives: This study aimed to evaluate the concordance of vaccine strains with circulating influenza viruses and the emergence of neuraminidase inhibitor (NAI) resistance in China. Methods: Data on antigenic characterization and antiviral susceptibility testing were extracted from weekly influenza surveillance reports published by the Chinese National Influenza Center from 2015 to 2025. Viral evolution, substitutions at key antigenic sites, and resistance-associated mutations were further examined based on sequences of circulating influenza viruses in China. Results: The overall vaccine match rates were 95.72% (95% CI: 94.02-97.43%) for A(H1N1)pdm09, 58.96% (95% CI: 54.93-62.96%) for A(H3N2), 64.45% (95% CI: 59.49-69.41%) for B/Victoria, and 95.19% (95% CI: 91.32-99.05%) for B/Yamagata in China during the 2015-2025 influenza seasons, with marked year-to-year fluctuations observed particularly for A(H3N2) and B/Victoria. The vaccine matching for cell-based A(H3N2) (70.41%, 95% CI: 65.04-75.77%) vaccine reference strains was significantly higher than that for egg-based A(H3N2) (48.09%, 95% CI: 42.63-53.55%) vaccine reference strains. Sequence analysis indicated that circulating A(H3N2) viruses showed the greatest genetic divergence from the matched egg-based vaccine strains (2.71%, 95% CI: 2.66-2.75%). Phenotypic NAI resistance was detected only in A(H1N1)pdm09 viruses, with resistance rates of 0.18% (95% CI: 0.07-0.45%) in 2023, 3.47% (95% CI: 2.63-4.57%) in 2024, and 3.01% (95% CI: 2.46-3.68%) in 2025. Neuraminidase (NA) sequence analysis showed that the key NAI resistance-associated substitution H274Y has been detected in A(H1N1)pdm09 viruses since 2015, at relatively high frequencies observed during 2015-2018. The mutation re-emerged in 2023 and presented increase trends thereafter, although no A(H1N1) pdm09 circulated during the COVID-19 pandemic. Conclusions: Antigenic concordance between vaccine strains and circulating A(H3N2) or B/Victoria viruses showed marked year-to-year fluctuations in China. Cell-based A(H3N2) vaccine reference strains showed higher antigenic concordance than egg-based strains, supporting further consideration of vaccine production platforms in A(H3N2)-predominant seasons. Phenotypic NAI resistance in circulating A(H1N1)pdm09 viruses was detected from 2023 onward in China, whereas resistance-associated NA substitutions had been detected earlier at the sequence level.

PMID 42506623
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PubMedVaccines2026-07-27

Evaluation of Immunogenicity and Cross-Protective Efficacy of a CpG-Adjuvanted Trivalent Inactivated Influenza Vaccine in Ferrets.

Qiu Yanping Y, Zhang Yan Y, He Shuangshuang S, Wang Yutian Y et al.

Background/Objectives: Pandemic influenza remains a persistent global threat, and while vaccination is the primary preventive measure, conventional vaccines often induce narrow, strain-specific immunity. This study evaluated the immunogenicity, protective efficacy, and cross-protective potential of a CpG-adjuvanted trivalent inactivated influenza vaccine (CpG-TIV) administered intramuscularly at high and low doses in ferrets. Methods: Groups of influenza-seronegative ferrets received two intramuscular injections, 3 weeks apart, of high- or low-dose CpG-TIV or a commercial non-adjuvanted trivalent vaccine. Three weeks after the second immunization (Day 42), serum was obtained, and the ferrets were subsequently challenged intranasally with homologous H1N1 and influenza B viruses, as well as a heterologous drifted H3N2 strain. Clinical signs, body weight, nasal viral load, and lung histopathology were monitored following the viral challenge. Results: CpG-TIV induced significantly higher dose-dependent HI and IgG antibodies than the commercial unadjuvanted vaccine. High-dose CpG-TIV markedly reduced weight loss, clinical symptoms, nasal viral load (by up to 99%), and lung pathological damage. Notably, high-dose CpG-TIV provided significant cross-protection against heterologous H3N2, whereas the commercial vaccine showed no protective effect. At Day 42, HI GMTs in the high-dose group reached 500, 254, and 594 against H1N1, H3N2, and B strains, respectively, with a maximal 2.58 log10 reduction in H1N1 viral load. Conclusions: High-dose CpG-TIV demonstrates strong immunogenicity and robust dose-dependent homologous and heterologous cross-protection in ferrets. The combination of a CpG adjuvant and high-dose antigen broadens protection against drifted influenza viruses, overcoming the narrow coverage of conventional vaccines. These data support further clinical development of this broad-spectrum influenza vaccine candidate.

PMID 42506652
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PubMedVaccines2026-07-27

Influenza B Vaccines: Current Landscape and Novel Development Strategies.

Kotlyarov Roman Y RY, Ravin Nikolai V NV, Mardanova Eugenia S ES

Influenza B virus (IBV) represents a significant global health threat, contributing 20-30% of annual influenza cases and causing substantial morbidity and mortality across all age groups. Current seasonal vaccines demonstrate variable effectiveness, highlighting the urgent need for next-generation approaches that provide enhanced and sustained protection against both IBV lineages. Moreover, continuous antigenic drift of circulating viruses progressively reduces the match between vaccine-induced antibodies and contemporary strains, necessitating broad-spectrum protection strategies. This review discusses influenza B virus control strategies, encompassing both conventional approaches and emerging vaccine technologies. While antiviral therapy, epidemiological surveillance, diagnostics, and non-pharmaceutical public-health measures are integral components of influenza B control, the present review focuses specifically on vaccine-based strategies. By critically appraising the available evidence, this review evaluates the extent to which these strategies may improve the effectiveness of IBV vaccines and, in the longer term, inform the prospect of reducing the burden of-or potentially eliminating-influenza B virus, a goal that remains hypothetical and requires clinical validation.

PMID 42506610
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PubMedEmerging microbes & infections2026-07-27

Porcine Airway Organoids Reveal Strain-Associated Replication and Epithelial Host Response Signatures of a Reassortant H1N1 Virus.

Lee Hyewon H, Shin Yeojin Y, Heo Ji-Young JY, Yu Aaron A et al.

Pigs serve as mixing vessels for influenza A viruses, facilitating reassortment and the emergence of variants with zoonotic potential. Since the 2009 pandemic, human-origin influenza gene segments have been repeatedly detected in swine populations, contributing to the generation of genetically diverse reassortant viruses. However, assessing the infection phenotypes and epithelial host responses of newly emerging reassortant swine influenza viruses remains challenging using conventional in vitro and in vivo approaches. Here, we established long-term expanding three-dimensional porcine airway organoids (pAOs) as a platform for the phenotypic and transcriptomic characterization of reassortant influenza viruses. We compared the infection phenotypes of a recently identified reassortant H1N1 virus, SNU01/H1N1/2023, with those of a classical swine-lineage H1N1 strain, GC0503/H1N1/2005, and the 2009 pandemic strain, CA04/H1N1/2009. All viruses productively infected pAOs, while SNU01 yielded higher levels of infectious progeny than the comparator strains. Bulk transcriptomic profiling at 24 h post-infection revealed that SNU01 infection was associated with an epithelial host-response profile more similar to CA04 than to GC0503, characterized by stronger epithelial antiviral and inflammatory transcriptional activation. Notably, SNU01 infection was associated with distinct cytoskeleton-associated transcriptional programs that were not prominent in the comparator infections. These findings demonstrate that porcine airway organoids can distinguish strain-associated differences in viral replication and epithelial host responses, providing a tractable platform for the comparative characterization of reassortant influenza viruses.

PMID 42504738
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PubMedVaccines2026-07-27

Pilot-Scale Downstream Processing of Recombinant Influenza Virus Vectors Expressing Brucella spp. Antigens Using an Integrated Membrane-Chromatography Purification Platform.

Assanzhanova Nurika N, Sagymbayeva Aigerim A, Shynybekova Gaukhar G, Shorayeva Kamshat K et al.

Background: Brucellosis remains a significant zoonotic infection affecting approximately 500,000 people worldwide annually, with no licensed human vaccine available. Recombinant influenza virus vectors expressing Brucella spp. antigens represent a promising vaccine platform. However, transitioning from laboratory constructs to clinical candidates requires validation of scalable purification methods compliant with Good Manufacturing Practice (GMP) standards. This study aimed to develop and optimize a pilot-scale purification protocol for these vectors. Methods: Recombinant influenza A viruses (H5N1) expressing Brucella spp. antigens (Omp16, Omp19, L7/L12, Cu-Zn SOD) were propagated in MDCK cell culture. The optimized purification process included: (1) clarification; (2) ultrafiltration/diafiltration (100 kDa MWCO); (3) two-step chromatography (anion-exchange Q-Sepharose® Fast Flow and multimodal Capto™ Core 700); and (4) sterile filtration. Process validation was performed across three independent pilot-scale batches (20 L each). Results: The purification process demonstrated high reproducibility for all constructs. Final preparations met established quality criteria: infectious titer ≥ 5.2 log10 TCID50/mL, hemagglutination activity 7.33 ± 0.58-8.33 ± 0.58 log2, total protein content 157-305 μg/mL, residual host cell DNA < 10 ng/dose, and bacterial endotoxin levels ≤ 0.15 IU/mL. The overall recovery of infectious virus was 20-24%, an optimal value for multi-stage bioprocessing. Preservation of the target genetic insert was confirmed in all final preparations by PCR and sequencing. Conclusions: The developed integrated purification protocol yields vectors with high purification efficiency, preserving biological activity and meeting regulatory quality requirements for residual host cell DNA and endotoxins. The technological platform demonstrated versatility, robustness (inter-batch coefficient of variation for yield did not exceed 10-12%), and scalability, establishing a foundation for preclinical and clinical studies of candidate brucellosis vaccines.

PMID 42506663
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PubMedVaccines2026-07-27

Recombinant EHV-1 Vector Expressing Immunodominant Hemagglutinin Protein of Equine Influenza Virus H3N8 (Sub-Lineage Florida Clade 2).

Bera Bidhan Chandra BC, Bernela Manju M, Madhwal Aashwina A, Pradhan Stephanie S SS et al.

Equine herpesvirus type 1 (EHV-1) and equine influenza virus (EIV) are major respiratory pathogens in horses, causing significant economic losses in domesticated horses. Bacterial Artificial Chromosome (BAC) technology can be used to precisely manipulate the EHV-1 genome for the development of live-attenuated vector vaccines. Earlier, our group developed a live-attenuated EHV-1 vaccine by deleting virulence-associated genes using this technology and the mutant EHV-1 has been exploited for expressing foreign gene in the current study. Specifically, in this study, a mutant EHV-1 virus expressing the hemagglutinin (HA) gene of H3N8 EIV (sub-lineage: Florida clade 2) was generated and characterized in vitro. The HA gene of EIV (Florida clade 2) was used for antigen gene cloning. The expression cassette for the HA gene was commercially synthesized and inserted into the backbone of EHV1∆IR6 BAC using an En passant mutagenesis strategy. Recombinant clones were selected using antibiotic selection, PCR, and RFLP. Further, the recombinant virus was regenerated in RK-13 cells via transfection and characterized in vitro for plaque size, growth kinetics and immunofluorescence antibody test (IFAT). PCR and RFLP confirmed the successful insertion of the HA gene into pEHV1∆IR6/gE BAC. The recombinant virus, vEHV1∆IR6/gE-HA(FC2), was successfully rescued in RK13 cells and demonstrated expression of the EIV haemagglutinin proteins by immunofluorescence assay. Although plaque size was reduced in the generated mutant virus in comparison to parental virus, the growth kinetics of the recombinant viruses were comparable to those of vEHV1∆IR6/gE. These findings demonstrate the successful expression of immunodominant hemagglutinin protein of EIV by recombinant EHV-1 and indicate the potential suitability of EHV-1 BAC as a vector platform for foreign gene expression.

PMID 42506671
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