Registration Number
0225U000777,
(0122U000974)
, R & D reports
Title
Immunogenicity and specificity of protein antigens and neoadjuvant mixures ex vivo
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Оцінка тривалості імунної відповіді у тварин
Head
Bilyi Rostyslav O., Доктор біологічних наук
Registration Date
18-01-2025
Organization
Danylo Halytsky Lviv National Medical University
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To evaluate the immune response of human leukocytes ex vivo to the action of the nanocarriers combined with recombinant SARS-CoV-2 coronavirus protein S polypeptides.
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An immunogenic mixture was developed based on a recombinant SARS-CoV-2 antigen and nano-adjuvants derived from nanodiamonds. The antigen represents a part of the S protein (RBD domain) and can be either synthetic or recombinant. A method for attaching the antigen to nanoparticles to create a stable mixture has been developed, with a patent application submitted in Ukraine. Testing of the immunogenic mixture within the project demonstrated an effective and sustained immune response, with antibody levels maintained for up to 360 days in Balb/c laboratory mice and rabbits. The dominant antibody subclass was IgG1. The mixture retained its activity during storage at -20°C, with short-term storage periods at +4°C. The minimal dose of adjuvant required to induce an immune response was determined to be 1 mg per injection in a series of two immunizations. Deposits of the immunogenic mixture in tissues were examined one year after administration, confirming their passivation and biocompatibility. Effectiveness depended on the ability of neutrophils to generate an oxidative burst at the site of adjuvant administration.
In animal models of chronic inflammatory conditions, neutrophil depletion or reduced oxidative burst capacity led to less effective nano-adjuvant performance. Ex vivo studies with human blood components showed that the immunogenic mixture primarily activated neutrophils, to a lesser extent monocytes, and did not activate lymphocytes. The research focused on the effectiveness of blood cell activation (ex vivo) in patients with autoimmune disorders was performed. A model of coronavirus infection was established in hamsters, and lung tissue samples positive for coronavirus antigen were obtained. The ability of immunoglobulins from the sera of immunized mice to recognize viral antigens in the tissues of hamsters infected with clinical COVID patient samples was demonstrated. UA patent application was claimed, 3 articles were published in Q1 journals, 2 in Q4.
Product Description
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Bila Halyna I.
Volodymyr I. Vovk
Hrytsko Roman Yu.
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2025-01-18