Gamma-irradiated SARS-CoV-2 vaccine candidate, OZG-38.61.3, confers protection from SARS-CoV-2 challenge in human ACEII-transgenic mice

Abstract The SARS-CoV-2 virus caused the most severe pandemic around the world, and vaccine development for urgent use became a crucial issue. Inactivated virus formulated vaccines such as Hepatitis A and smallpox proved to be reliable approaches for immunization for prolonged periods. In this study...

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Autores principales: Raife Dilek Turan, Cihan Tastan, Derya Dilek Kancagi, Bulut Yurtsever, Gozde Sir Karakus, Samed Ozer, Selen Abanuz, Didem Cakirsoy, Gamze Tumentemur, Sevda Demir, Utku Seyis, Recai Kuzay, Muhammer Elek, Miyase Ezgi Kocaoglu, Gurcan Ertop, Serap Arbak, Merve Acikel Elmas, Cansu Hemsinlioglu, Ozden Hatirnaz Ng, Sezer Akyoney, Ilayda Sahin, Cavit Kerem Kayhan, Fatma Tokat, Gurler Akpinar, Murat Kasap, Ayse Sesin Kocagoz, Ugur Ozbek, Dilek Telci, Fikrettin Sahin, Koray Yalcin, Siret Ratip, Umit Ince, Ercument Ovali
Formato: article
Lenguaje:EN
Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/0080510c27ab4fa68a13783ab005d11d
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Sumario:Abstract The SARS-CoV-2 virus caused the most severe pandemic around the world, and vaccine development for urgent use became a crucial issue. Inactivated virus formulated vaccines such as Hepatitis A and smallpox proved to be reliable approaches for immunization for prolonged periods. In this study, a gamma-irradiated inactivated virus vaccine does not require an extra purification process, unlike the chemically inactivated vaccines. Hence, the novelty of our vaccine candidate (OZG-38.61.3) is that it is a non-adjuvant added, gamma-irradiated, and intradermally applied inactive viral vaccine. Efficiency and safety dose (either 1013 or 1014 viral RNA copy per dose) of OZG-38.61.3 was initially determined in BALB/c mice. This was followed by testing the immunogenicity and protective efficacy of the vaccine. Human ACE2-encoding transgenic mice were immunized and then infected with the SARS-CoV-2 virus for the challenge test. This study shows that vaccinated mice have lowered SARS-CoV-2 viral RNA copy numbers both in oropharyngeal specimens and in the histological analysis of the lung tissues along with humoral and cellular immune responses, including the neutralizing antibodies similar to those shown in BALB/c mice without substantial toxicity. Subsequently, plans are being made for the commencement of Phase 1 clinical trial of the OZG-38.61.3 vaccine for the COVID-19 pandemic.