Aug 2026· Vaccine· Vol 91, pp.
129048
· 0 citations· 12 references
Medicine
TL;DR
Overall, NIID-002 fulfills the key requirements for the pandemic preparedness of CVV, combining reduced pathogenicity, broad antigenic reactivity, and adequate production efficiency, which underscores the continued need for surveillance and refinement of influenza vaccine strategies to address evolving viral threats.
Abstract
The development of candidate vaccine viruses (CVVs) for pre-pandemic preparedness requires attenuation of pathogenicity while maintaining immunogenicity. In this study, we developed and characterized NIID-002, a reassortant virus derived from A/Ezo red fox/Hokkaido/1/2022 (H5N1; clade 2.3.4.4b), to evaluate its suitability as a candidate vaccine. NIID-002 exhibited markedly reduced pathogenicity compared with its parental strain, while retaining broad antigenic reactivity and protein yield comparable to other clade 2.3.4.4b CVVs. In mammalian models, NIID-002 demonstrated strong attenuation, causing no lethal infection in mice and only minimal weight loss with limited viral replication in ferrets. Antisera raised against NIID-002 reacted broadly with recent wild-type H5N1 isolates, suggesting potential broad protection. Protein yield analysis confirmed a production efficiency comparable to that of other CVVs within the same clade, supporting its feasibility for large-scale vaccine manufacturing. Overall, NIID-002 fulfills the key requirements for the pandemic preparedness of CVV, combining reduced pathogenicity, broad antigenic reactivity, and adequate production efficiency. These findings highlight its potential as a candidate H5N1 vaccine and underscore the continued need for surveillance and refinement of influenza vaccine strategies to address evolving viral threats.
Highly pathogenic avian influenza (HPAI) virus H5N1of clade 2.3.4.4b has emerged as the predominant lineage circulating in poultry flocks worldwide, raising concerns regarding the protective efficacy of currently available commercial vaccines, particularly in domestic ducks, which play an important role in virus maintenance and transmission. Thus, this study evaluated the immunogenicity along with the protective efficacy of four inactivated H5 vaccines against a recently isolated local HPAI-H5N1 (Newvalley-3-H5N1-2024, clade 2.3.4.4b) strain in Pekin ducks in Egypt. A total of 150 seronegative ducks were divided into vaccinated and control groups (10 groups) and vaccinated at 10 days of age. At 31 days of age, the vaccinated and positive control groups were challenged using 106.5 EID50/0.5 mL/duck with the local isolate (Newvalley-3-H5N1-2024) via the oculo-nasal route. The vaccine efficacy was assessed through clinical signs, survival rate, hemagglutination inhibition (HI) antibody titer, tracheal and cloacal viral shedding quantified by real-time RT-PCR, and histopathological examination of trachea, lung, pancreas, and brain tissues. Generally, all ducks vaccinated with the ValleyVac Avian Flu H5 plus and MEFLUVACTM H5 PLUS 8 showed a significantly higher survival rate (100%) at 10 days post-vaccination (DPV) than those in the positive control (66.7% mortality rate). In contrast, ducks exhibited mortality rates ranging from 6.7% in the SERVAC Flu H5N1 group to 13.4% in the Sinder Fluvac group. The ValleyVac Avian Flu H5 plus and MEFLUVAC™ H5 PLUS 8 vaccines induced the highest HI antibody titers at 7, 14, 21, and 28 DPV in both homologous and heterologous AIV antigens, resulting in a significant reduction in viral load among all vaccinated duck groups (p-value < 0.05) comparable to the positive control group. Conversely, the SERVAC Flu H5N1 and Sinder Fluvac vaccines provided partial protection, suboptimal immunogenicity at different time points, and elevated viral shedding. Histopathological findings in ValleyVac Avian Flu H5 plus and MEFLUVAC™ H5 PLUS 8 vaccines exhibited mild tissue alterations following AIV challenge. Marked pathological lesions were observed in the SERVAC Flu H5N1 and Sinder Fluvac vaccinated groups. Among tested vaccines, both ValleyVac Avian Flu H5 plus and MEFLUVACTM H5 PLUS 8 showed the highest level of protective efficacy against the circulating AIV strain compared with other commercial vaccines. This study highlights the need for continuous molecular surveillance, antigenic matching, and regular updating of vaccine seed strains to ensure efficient HPAI control in Egypt.
Eman Abd El Menum Shosha, I. Eldaghayes, Ahmed A. H. Ali et al.· Viruses· 0 citations
The report highlights the genetic and antigenic features of a clade 2.3.4b HPAI H5N1 virus isolated from a free-range layer duck in the Kuttanad delta of Kerala, India, in 2022, suggesting a role for these birds in its introduction.
K. Gaurav, Manoj Kumar, S. Nagarajan et al.· Journal of Pure and Applied...· 0 citations
Highly pathogenic avian influenza (HPAI) A(H5N1) clade 2.3.4.4b virus continues to spread globally and sporadically transmits from avian reservoirs to mammalian hosts. In May 2024, H5N1 infections in young goats and alpacas in the United States were reported. Nevertheless, the overall susceptibility of camelids to clade 2.3.4.4b virus remains unclear. We conducted a controlled experimental infection study in 6 alpacas, assessing clinical signs, viral shedding, tissue distribution, and serologic responses after intranasal inoculation with HPAI H5N1 genotype B3.13 virus. Observed illness was generally mild; body temperature increased slightly and food intake reduced for up to 3 days postinfection. We detected viral RNA in nasal swab samples and confirmed infectious HPAI H5N1 virus. Immunohistochemistry and RNA in situ hybridization detected virus only in the nasopharyngeal tonsil and nasal conchae at 4 days postinfection. Our findings suggest alpacas are susceptible to productive H5N1 infection, highlighting implications for livestock surveillance and biosecurity in regions with ongoing circulation.
Jacob Schön, A. Breithaupt, N. Halwe et al.· Emerging Infectious Diseases· 0 citations
Avian influenza virus (AIV) and infectious bronchitis virus (IBV) are major respiratory pathogens of poultry, and their co-circulation complicates disease control. Here, we developed a chimeric subunit vaccine, RBD-HA, in which the receptor-binding domain (RBD) of the QX-type IBV spike protein replaced the immunodominant head domain of H9N2 AIV haemagglutinin. Structural analyses showed that RBD-HA formed a stable trimeric assembly, supporting the use of the HA stalk as an antigen-presenting scaffold. In chickens, RBD-HA induced humoral responses against both viruses and protected against homologous and heterologous H9N2 AIV challenge. In parallel, RBD-HA induced IBV-reactive and neutralizing antibody responses and provided protection against QX-type IBV challenge. The vaccine also elicited cross-reactive neutralizing activity and reduced viral shedding and tissue damage after H6N6 AIV challenge. These findings provide proof of concept for a bivalent subunit vaccine targeting two major avian respiratory viruses.
It is demonstrated that the AS03-adjuvanted A(H5N8)-based stockpiled vaccine provides strong cross-protective efficacy against bovine A(H5N1) viruses during the early phase of a pandemic.
Ryuta Uraki, M. Kiso, Kiyoko Iwatsuki-Horimoto et al.· EBioMedicine· 0 citations
ABSTRACT Background The high‐pathogenicity avian influenza (HPAI) viruses represent a main threat to animal and human health, poultry productivity, and ecosystems. The newly evolved A(H5N1) clade 2.3.4.4b has become a worldwide concern for its expanding multihost ecology, including poultry and a wide range of mammalian species. Methods Avian influenza virus (AIV) was isolated from an outbreak in commercial quail farms associated with severe respiratory signs and high mortality. Molecular characterization of the detected virus was performed through gene sequencing via whole‐genome sequencing technology and phylogenetic analysis. Results Genetic and phylogenetic analyses revealed that the hemagglutinin (HA) gene clustered closely with a recent HPAI A(H5N1) clade 2.3.4.4b strain from live bird markets (LBMs) in Bangladesh, with a most recent common ancestor dated to July 2023. The NA gene and four internal genes (PB1, NP, MP, NS) were derived from contemporary A(H5N1) viruses of ducks in LBMs, while the PB2 and PA segments exhibited similarity to low pathogenicity avian influenza (LPAI) viruses, suggesting reassortment events within avian hosts. The presence of a multibasic cleavage site (PLREKRRKR↓GLF) with avian‐specific receptor‐binding residues (Q224 and G226) and five conserved glycosylation motifs, consistent with high‐pathogenicity phenotypes and strong avian receptor affinity. The PB2 gene harbored a rare I147T substitution; however, key mammalian adaptation markers such as E627K and D701N were absent. Conclusion The reassortant A(H5N1) clade 2.3.4.4b virus with high pathogenicity and genetic links to LBM‐origin strains is now circulating in the commercial poultry population in Bangladesh, increasing the risk of viral adaptation, the potential for cross‐species transmission, and threatening the poultry sector and public health.
M. A. Samad, Md Rezaul Karim, Amelia Coggon et al.· Influenza and Other Respirat...· 0 citations
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