A Phase I/II Randomized, Double-blind, Positive-controlled Dose-exploration Study to Evaluate the Safety and Immunogenicity of a Virus-like Particle (VLP) Based Vaccine Against Poliomyelitis (VLP-Polio) in Infants From 6 Weeks of Age and Toddlers 12-18 Months of Age

This is a phase I/II randomized, double-blind, and positive-controlled study. Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio (Dose H) or control vaccine in a ratio of 3:1. The phase I infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Phase II infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Each infant participant will be administrated 3 doses of the assigned vaccine with 28 days apart, and the booster dose will be given when the infant is 12-18 months old. Enrollment of Phase I and Phase II will be staggered in descending order of age group but ascending order of dosing levels. Blood and mucosal samples will be collected for immunogenicity evaluation over the time course of the study.

开始日期2024-10-01

申办/合作机构

康希诺生物股份公司

NCT06101173 / Active, not recruiting临床1期

A Randomized, Observer-Blind, Positive-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults Aged 18-54 Years

This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.

开始日期2024-01-15

申办/合作机构

康希诺生物股份公司

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100 项与 Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (CanSino Biologics) 相关的临床结果

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100 项与 Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (CanSino Biologics) 相关的转化医学

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100 项与 Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (CanSino Biologics) 相关的专利（医药）

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项与 Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (CanSino Biologics) 相关的文献（医药）

2024-01-01·International Journal of Biological Macromolecules

Intrinsic disorder in the dynamic evolution of structure, stability, and flexibility of potyviral VLP assemblies: A computational study

Article

作者: Pacios, Luis F ; Ponz, Fernando ; Sánchez, Flora

An all-atom Molecular Dynamics (MD) study was applied to three viral nanoparticles (VLPs) of Turnip mosaic virus (TuMV), a potyvirus: the particles genetically functionalized with two peptides, VIP (human vasoactive intestinal peptide) and VEGFR (peptide derived from the human receptor 3 of the vascular endothelial growth factor), and the non-functionalized VLP. Previous experimental results showed that VIP-VLP was the only construct of the three that was not viable. VLPs subjected to our MD study were modeled by four complete turns of the particle involving 35 subunits of the coat protein (CP). The MD simulations showed differences in structures and interaction energies associated to the crucial contribution of the disordered N-terminal arms of CP to the global stability of the particle. These differences suggested an overall stability greater in VEGFR-VLP and smaller in VIP-VLP as compared to the unfunctionalized VLP. Our novel MD study of potyviral VLPs revealed essential clues about structure and interactions of these assembled protein particles and suggests that the computational prediction of the viability of VLPs can be a valuable contribution in the field of viral nanobiotechnology.

2022-02-01·Allergy

Virus‐like particles displaying recombinant Der p 1 zymogen to optimize IgG blocking antibody response

Letter

作者: Sander, Adam F. ; Jacquet, Alain ; Jitthamstaporn, Sirikarn

As repetitive arrays of antigens in virus- like particles (VLPs) promote potent neutralizing antibody responses, we multimerized the major house dust mite (HDM) allergen Der p 1 on the surface of bacteriophage AP205 VLPs using the Split- protein (SpyCatcher- SC/SpyTag- ST) technol.Dynamic light scattering (DLS) anal. showed that VLP- pDp1N and VLP- pDp1C have a hydrodynamic diameter of 118 and 112 nm, resp., and with 26%- 27% polydispersity.Competitive ELISA IgE assays showed that, in solution, both VLP-pDp1 particles had a much lower IgE reactivity in comparison with natural Der p 1 (nDer p 1) or monomeric SpyTagged- pDp1 (p < 0.05).In conclusion, we demonstrated for the first time that the unidirectional display of full-length pDp1 at very high d. on VLP surfaces is a straightforward strategy to develop Der p 1- based hypoallergenic vaccines with the aim to trigger potent Der p 1- specific blocking IgG antibodies.

2020-12-01·BMC Genomics2区 · 生物学

Whole genome sequencing of Borrelia miyamotoi isolate Izh-4: reference for a complex bacterial genome

2区 · 生物学

ArticleOA

作者: Kuleshov, Konstantin V ; Markelov, Mikhail L ; Hovius, Joppe W ; Platonov, Alexander E ; Kolyasnikova, Nadezhda M ; Goptar, Irina A ; Fingerle, Volker ; Kirdyashkina, Nina P ; Sarksyan, Denis S ; Shipulin, German A ; Margos, Gabriele ; Koetsveld, Joris

AbstractBackgroundThe genus Borrelia comprises spirochaetal bacteria maintained in natural transmission cycles by tick vectors and vertebrate reservoir hosts. The main groups are represented by a species complex including the causative agents of Lyme borreliosis and relapsing fever group Borrelia. Borrelia miyamotoi belongs to the relapsing fever group of spirochetes and forms distinct populations in North America, Asia, and Europe. As all Borrelia species B. miyamotoi possess an unusual and complex genome consisting of a linear chromosome and a number of linear and circular plasmids. The species is considered an emerging human pathogen and an increasing number of human cases are being described in the Northern hemisphere. The aim of this study was to produce a high quality reference genome that will facilitate future studies into genetic differences between different populations and the genome plasticity of B. miyamotoi.ResultsWe used multiple available sequencing methods, including Pacific Bioscience single-molecule real-time technology (SMRT) and Oxford Nanopore technology (ONT) supplemented with highly accurate Illumina sequences, to explore the suitability for whole genome assembly of the Russian B. miyamotoi isolate, Izh-4. Plasmids were typed according to their potential plasmid partitioning genes (PF32, 49, 50, 57/62). Comparing and combining results of both long-read (SMRT and ONT) and short-read methods (Illumina), we determined that the genome of the isolate Izh-4 consisted of one linear chromosome, 12 linear and two circular plasmids. Whilst the majority of plasmids had corresponding contigs in the Asian B. miyamotoi isolate FR64b, there were only four that matched plasmids of the North American isolate CT13–2396, indicating differences between B. miyamotoi populations. Several plasmids, e.g. lp41, lp29, lp23, and lp24, were found to carry variable major proteins. Amongst those were variable large proteins (Vlp) subtype Vlp-α, Vlp-γ, Vlp-δ and also Vlp-β. Phylogenetic analysis of common plasmids types showed the uniqueness in Russian/Asian isolates of B. miyamotoi compared to other isolates.ConclusionsWe here describe the genome of a Russian B. miyamotoi clinical isolate, providing a solid basis for future comparative genomics of B. miyamotoi isolates. This will be a great impetus for further basic, molecular and epidemiological research on this emerging tick-borne pathogen.

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