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KR-102961250-B1 - A composition for preventing or treating coronavirus comprising SCoV2-RBD fusion protein

KR102961250B1KR 102961250 B1KR102961250 B1KR 102961250B1KR-102961250-B1

Abstract

The invention relates to a recombinant antigen protein in which Co4B, an antigen-uptake cell-targeting material capable of inducing and enhancing mucosal and systemic immune responses, and HBD2 (human beta-defensin 2), an innate immunity-mediated immune response enhancing material, are fused to the receptor-binding domain (SCoV2-RBD) of the SARS-CoV-2 spike protein, and a vaccine composition for the prevention and treatment of coronavirus infection containing the same. According to the present invention, the recombinant antigen and vaccine composition in which the antigen protein of the receptor-binding domain (SCoV2-RBD, RBD19) of the SARS-CoV-2 spike protein is fused with Co4B at the C-terminus and HBD2 at the N-terminus are useful for inducing long-term immunity, including antigen-specific antibodies and T-cell responses, and for having preventive efficacy against coronavirus.

Inventors

  • 장용석
  • 김주
  • 조별희

Assignees

  • 전북대학교산학협력단

Dates

Publication Date
20260511
Application Date
20231214

Claims (10)

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  6. A vaccine composition for preventing or treating coronavirus infection comprising an RBD19 protein having the amino acid sequence of SEQ ID NO. 2, The above composition comprises the amino acid sequence of SEQ ID NO. 1, in which Co4B is additionally bound to the C-terminus of the RBD19 protein and HBD2 (human beta-defensin 2) is additionally bound to the N-terminus. A vaccine composition for preventing or treating coronavirus infection, wherein the above composition is administered via one or more routes selected from the group consisting of nasal, oral, intramuscular, intraperitoneal, intravenous, transdermal, and subcutaneous.
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  8. In Paragraph 6, The above composition is a vaccine composition for preventing or treating coronavirus infection, which increases the production of antigen-specific antibodies.
  9. In Paragraph 6, The above composition is a vaccine composition for preventing or treating coronavirus infection, which increases an antigen-specific T-cell-mediated immune response.
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Description

A fusion protein comprising the receptor-binding domain (SCoV2-RBD) of a spike protein and a vaccine composition for preventing or treating coronavirus infection comprising the same The invention relates to a recombinant antigen protein in which Co4B, an antigen-uptake cell-targeting material capable of inducing and enhancing mucosal and systemic immune responses, and HBD2 (human beta-defensin 2), an innate immune-mediated immune response enhancing material, are fused to the receptor-binding domain (SCoV2-RBD) of the SARS-CoV-2 spike protein, and a vaccine composition for the prevention and treatment of coronavirus infection containing the same. Following the regional outbreaks of SARS-CoV (Severe Acute Respiratory Syndrome-Coronavirus) in 2002 and MERS-CoV (Middle East Respiratory Syndrome) in 2012 in Saudi Arabia and South Korea, the first case of respiratory pneumonia of unknown origin was reported to the WHO in Wuhan, Hubei Province, China, in December 2019. Since then, the virus has rapidly spread globally beyond community transmission through person-to-person contact. Early in the pandemic, two types of COVID-19 mRNA vaccines (Moderna mRNA-1273 and Pfizer/BioNTech BNT162b2) were developed and received Emergency Use Authorization from the FDA. Subsequently, various COVID-19 vaccines, including inactivated and viral vector vaccines, were approved, followed by the approval of Novavax, a traditional protein subunit type vaccine, for Emergency Use. Due to the availability of these various types of vaccines, xenogeneic prime-boost vaccinations were carried out worldwide, and these xenogene The prime-boost strategy has been reported to induce a more potent T-cell response and higher neutralizing antibody titers. Furthermore, since repeated administration of mRNA vaccines has been reported to cause side effects such as myocarditis or hypersensitivity compared to traditional protein subunit vaccines, there is a need for a heterogeneous vaccine strategy involving the development of relatively safe and effective recombinant protein vaccines to be used in combination with mRNA vaccines, viral vector vaccines, and inactivated vaccines. Additionally, given the constant possibility of a resurgence due to the continuous mutation of the coronavirus, the development of effective and safe booster shot vaccines is necessary. Accordingly, the inventors of the present invention, aiming to overcome the limitation that most commercially available COVID-19 vaccines are intramuscular vaccines that are difficult to effectively induce a local immune response in the respiratory mucosa, completed a recombinant antigen protein by fusing Co4B, which can induce and enhance mucosal and systemic immune responses—the main infection pathway—and HBD2, an innate immunity-mediated immune response enhancing material, to the receptor-binding domain (SCoV2-RBD) of the SARS-CoV-2 spike protein. They confirmed the induction of long-term immunity and preventive efficacy against coronavirus, including antigen-specific antibody immune responses and T-cell-mediated immune responses, and completed the present invention. Figure 1 shows the structure of the HBD2-RBD19-Co4B fusion protein. Figure 2 confirms the increase in antigen-specific antibody production in the systemic/mucosal area caused by HBD2-RBD19-Co4B. Figure 3 confirms the increase in antigen-specific T-cell-mediated immune responses in the spleen and NALT by HBD2-RBD19-Co4B. Figure 4 confirms the increase in antigen-specific T-cell-mediated immune responses in the lungs caused by HBD2-RBD19-Co4B. Figure 5 confirms the effect of maintaining an immune response in the systemic/mucosal area by HBD2-RBD19-Co4B. Figure 6 confirms the effect of maintaining the immune response in NALT by HBD2-RBD19-Co4B. Figure 7 confirms the effect of maintaining an immune response in the lungs by HBD2-RBD19-Co4B. Figure 8 confirms the protective ability against SARS-CoV-2 by HBD2-RBD19-Co4B. Figure 9 confirms the increase in antigen-specific antibody production in hACE2 transgenic mice (hACE2-KI) induced by HBD2-RBD19-Co4B. Figure 10 confirms the protective ability against SARS-CoV-2 by HBD2-RBD19-Co4B in hACE2-KI. The present invention will be described in more detail below. However, the present invention may be implemented in various different forms, and the present invention is not limited by the embodiments described herein. The terms used herein are merely for describing specific embodiments and are not intended to limit the invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In the specification of the invention, the term 'comprising' any component means that, unless specifically stated otherwise, it does not exclude other components but may include additional components. SARS-CoV-2 is a virus of the coronavirus (CoV) lineage that causes COVID-19 . It is a variant of SARS-CoV and penetrates respiratory epithelial cells, causing symptoms such as fever,