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Safety and Immunogenicity Evaluation of Inactivated whole-virus-SARS-COV-2 As Emerging Vaccine Development In Egypt

Amani A. Saleh, Mohamed A. Saad, Islam Ryan, Magdy Amin, Mohamed I. Shindy, Wael A. Hassan, Mahmoud Samir, Ayman A. Khattab, Sherein S. Abdelgayed, Mohamed G. Seadawy, Hossam M. Fahmy, Khaled Amer
doi: https://doi.org/10.1101/2021.03.01.433130
Amani A. Saleh
1A.R.C. Veterinary Serum Vaccine Research Institute (VSVRI) Cairo, Egypt
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  • For correspondence: dr.amani-ali@hotmail.com
Mohamed A. Saad
1A.R.C. Veterinary Serum Vaccine Research Institute (VSVRI) Cairo, Egypt
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Islam Ryan
2Egyptian Army Veterinary Corps, Cairo Egypt
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Magdy Amin
3Military Medical Services, Cairo, Egypt
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Mohamed I. Shindy
2Egyptian Army Veterinary Corps, Cairo Egypt
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Wael A. Hassan
5Egypt Center for Research and Regenerative Medicine, Cairo, Egypt
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Mahmoud Samir
5Egypt Center for Research and Regenerative Medicine, Cairo, Egypt
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Ayman A. Khattab
5Egypt Center for Research and Regenerative Medicine, Cairo, Egypt
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Sherein S. Abdelgayed
6Faculty of Veterinary Medicine, Cairo University, Giza, Egypt
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Mohamed G. Seadawy
4Main Chemical Laboratories, Egypt Army
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Hossam M. Fahmy
7Faculty of Medicine, Ain Shams University, Cairo, Egypt
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Khaled Amer
5Egypt Center for Research and Regenerative Medicine, Cairo, Egypt
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Abstract

The current worldwide pandemic COVID-19 is causing severe human health problems, with high numbers of mortality rates and huge economic burdens that require an urgent demand for safe, and effective and vaccine development. Our study was the first trail to development and evaluation of safety and immune response to inactivated whole SARS-COV-2 virus vaccine adjuvanted with aluminium hydroxide. We used characterized SARS-COV-2 strain, severe acute respiratory syndrome coronavirus 2 isolates (SARS-CoV-2/human/EGY/Egy-SERVAC/2020) with accession numbers; MT981440; MT981439; MT981441; MT974071; MT974069 and MW250352 at GenBank that isolated from Egyptian patients SARS-CoV-2-positive. Development of the vaccine was carried out in a BSL - 3 facilities and the immunogenicity was determined in mice at two doses (55µg and 100µg per dose). All vaccinated mice were received a booster dose 14 days post first immunization. Our results demonstrated distinct cytopathic effect on the vero cell monolayers induced through SARS-COV-2 propagation and the viral particles were identified as Coronaviridae by transmission electron microscopy. SARS-CoV-2 was identified by RT-PCR performed on the cell culture. Immunogenicity of the developed vaccine indicated the high antigen-binding and neutralizing antibody titers, regardless the dose concentration, with excellent safety profiles.However, no deaths or clinical symptoms in mice groups. The efficacy of the inactivated vaccine formulation was tested by wild virus challenge the vaccinated mice and detection of viral replication in lung tissues. Vaccinated mice recorded complete protection from challenge infection three weeks post second dose. SARS-COV-2 replication was not observed in the lungs of mice following SARS-CoV-2 challenge, regardless of the level of serum neutralizing antibodies. This finding will support the future trials for evaluation an applicable SARS-CoV-2 vaccine candidate.

Competing Interest Statement

The authors have declared no competing interest.

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The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted March 02, 2021.
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Safety and Immunogenicity Evaluation of Inactivated whole-virus-SARS-COV-2 As Emerging Vaccine Development In Egypt
Amani A. Saleh, Mohamed A. Saad, Islam Ryan, Magdy Amin, Mohamed I. Shindy, Wael A. Hassan, Mahmoud Samir, Ayman A. Khattab, Sherein S. Abdelgayed, Mohamed G. Seadawy, Hossam M. Fahmy, Khaled Amer
bioRxiv 2021.03.01.433130; doi: https://doi.org/10.1101/2021.03.01.433130
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Safety and Immunogenicity Evaluation of Inactivated whole-virus-SARS-COV-2 As Emerging Vaccine Development In Egypt
Amani A. Saleh, Mohamed A. Saad, Islam Ryan, Magdy Amin, Mohamed I. Shindy, Wael A. Hassan, Mahmoud Samir, Ayman A. Khattab, Sherein S. Abdelgayed, Mohamed G. Seadawy, Hossam M. Fahmy, Khaled Amer
bioRxiv 2021.03.01.433130; doi: https://doi.org/10.1101/2021.03.01.433130

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