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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...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
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.
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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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