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Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies
Since the emergence of SARS-CoV-2 at the end of 2019, 64 candidate vaccines are in clinical development and 173 are in the pre-clinical phase. Five types of vaccines are currently approved for emergency use in many countries (Inactivated, Sinopharm; Viral-vector, Astrazeneca, and Gamaleya Research I...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999656/ https://www.ncbi.nlm.nih.gov/pubmed/33802467 http://dx.doi.org/10.3390/vaccines9030214 |
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author | Kandeil, Ahmed Mostafa, Ahmed Hegazy, Rehab R. El-Shesheny, Rabeh El Taweel, Ahmed Gomaa, Mokhtar R. Shehata, Mahmoud Elbaset, Marawan A. Kayed, Ahmed E. Mahmoud, Sara H. Moatasim, Yassmin Kutkat, Omnia Yassen, Noha N. Shabana, Marwa E. GabAllah, Mohamed Kamel, Mina Nabil Abo Shama, Noura M. El Sayes, Mohamed Ahmed, Amira N. Elalfy, Zahraa S. Mohamed, Bassim MSA Abd El-Fattah, Safa N. El Hariri, Hazem Mohamed Abdel Kader, Mona Azmy, Osama Kayali, Ghazi Ali, Mohamed A. |
author_facet | Kandeil, Ahmed Mostafa, Ahmed Hegazy, Rehab R. El-Shesheny, Rabeh El Taweel, Ahmed Gomaa, Mokhtar R. Shehata, Mahmoud Elbaset, Marawan A. Kayed, Ahmed E. Mahmoud, Sara H. Moatasim, Yassmin Kutkat, Omnia Yassen, Noha N. Shabana, Marwa E. GabAllah, Mohamed Kamel, Mina Nabil Abo Shama, Noura M. El Sayes, Mohamed Ahmed, Amira N. Elalfy, Zahraa S. Mohamed, Bassim MSA Abd El-Fattah, Safa N. El Hariri, Hazem Mohamed Abdel Kader, Mona Azmy, Osama Kayali, Ghazi Ali, Mohamed A. |
author_sort | Kandeil, Ahmed |
collection | PubMed |
description | Since the emergence of SARS-CoV-2 at the end of 2019, 64 candidate vaccines are in clinical development and 173 are in the pre-clinical phase. Five types of vaccines are currently approved for emergency use in many countries (Inactivated, Sinopharm; Viral-vector, Astrazeneca, and Gamaleya Research Institute; mRNA, Moderna, and BioNTech/Pfizer). The main challenge in this pandemic was the availability to produce an effective vaccine to be distributed to the world’s population in a short time. Herein, we developed a whole virus NRC-VACC-01 inactivated candidate SARS-CoV-2 vaccine and tested its safety and immunogenicity in laboratory animals. In the preclinical studies, we used four experimental animals (mice, rats, guinea pigs, and hamsters). Antibodies were detected as of week three post vaccination and continued up to week ten in the four experimental models. Safety evaluation of NRC-VACC-01 inactivated candidate vaccine in rats revealed that the vaccine was highly tolerable. By studying the effect of booster dose in the immunological profile of vaccinated mice, we observed an increase in neutralizing antibody titers after the booster shot, thus a booster dose was highly recommended after week three or four. Challenge infection of hamsters showed that the vaccinated group had lower morbidity and shedding than the control group. A phase I clinical trial will be performed to assess safety in human subjects. |
format | Online Article Text |
id | pubmed-7999656 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-79996562021-03-28 Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies Kandeil, Ahmed Mostafa, Ahmed Hegazy, Rehab R. El-Shesheny, Rabeh El Taweel, Ahmed Gomaa, Mokhtar R. Shehata, Mahmoud Elbaset, Marawan A. Kayed, Ahmed E. Mahmoud, Sara H. Moatasim, Yassmin Kutkat, Omnia Yassen, Noha N. Shabana, Marwa E. GabAllah, Mohamed Kamel, Mina Nabil Abo Shama, Noura M. El Sayes, Mohamed Ahmed, Amira N. Elalfy, Zahraa S. Mohamed, Bassim MSA Abd El-Fattah, Safa N. El Hariri, Hazem Mohamed Abdel Kader, Mona Azmy, Osama Kayali, Ghazi Ali, Mohamed A. Vaccines (Basel) Article Since the emergence of SARS-CoV-2 at the end of 2019, 64 candidate vaccines are in clinical development and 173 are in the pre-clinical phase. Five types of vaccines are currently approved for emergency use in many countries (Inactivated, Sinopharm; Viral-vector, Astrazeneca, and Gamaleya Research Institute; mRNA, Moderna, and BioNTech/Pfizer). The main challenge in this pandemic was the availability to produce an effective vaccine to be distributed to the world’s population in a short time. Herein, we developed a whole virus NRC-VACC-01 inactivated candidate SARS-CoV-2 vaccine and tested its safety and immunogenicity in laboratory animals. In the preclinical studies, we used four experimental animals (mice, rats, guinea pigs, and hamsters). Antibodies were detected as of week three post vaccination and continued up to week ten in the four experimental models. Safety evaluation of NRC-VACC-01 inactivated candidate vaccine in rats revealed that the vaccine was highly tolerable. By studying the effect of booster dose in the immunological profile of vaccinated mice, we observed an increase in neutralizing antibody titers after the booster shot, thus a booster dose was highly recommended after week three or four. Challenge infection of hamsters showed that the vaccinated group had lower morbidity and shedding than the control group. A phase I clinical trial will be performed to assess safety in human subjects. MDPI 2021-03-03 /pmc/articles/PMC7999656/ /pubmed/33802467 http://dx.doi.org/10.3390/vaccines9030214 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ). |
spellingShingle | Article Kandeil, Ahmed Mostafa, Ahmed Hegazy, Rehab R. El-Shesheny, Rabeh El Taweel, Ahmed Gomaa, Mokhtar R. Shehata, Mahmoud Elbaset, Marawan A. Kayed, Ahmed E. Mahmoud, Sara H. Moatasim, Yassmin Kutkat, Omnia Yassen, Noha N. Shabana, Marwa E. GabAllah, Mohamed Kamel, Mina Nabil Abo Shama, Noura M. El Sayes, Mohamed Ahmed, Amira N. Elalfy, Zahraa S. Mohamed, Bassim MSA Abd El-Fattah, Safa N. El Hariri, Hazem Mohamed Abdel Kader, Mona Azmy, Osama Kayali, Ghazi Ali, Mohamed A. Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies |
title | Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies |
title_full | Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies |
title_fullStr | Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies |
title_full_unstemmed | Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies |
title_short | Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies |
title_sort | immunogenicity and safety of an inactivated sars-cov-2 vaccine: preclinical studies |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999656/ https://www.ncbi.nlm.nih.gov/pubmed/33802467 http://dx.doi.org/10.3390/vaccines9030214 |
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