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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MDPI AG
2021-03-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/9/3/214 |
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| author | Ahmed Kandeil Ahmed Mostafa Rehab R. Hegazy Rabeh El-Shesheny Ahmed El Taweel Mokhtar R. Gomaa Mahmoud Shehata Marawan A. Elbaset Ahmed E. Kayed Sara H. Mahmoud Yassmin Moatasim Omnia Kutkat Noha N. Yassen Marwa E. Shabana Mohamed GabAllah Mina Nabil Kamel Noura M. Abo Shama Mohamed El Sayes Amira N. Ahmed Zahraa S. Elalfy Bassim MSA Mohamed Safa N. Abd El-Fattah Hazem Mohamed El Hariri Mona Abdel Kader Osama Azmy Ghazi Kayali Mohamed A. Ali |
| author_facet | Ahmed Kandeil Ahmed Mostafa Rehab R. Hegazy Rabeh El-Shesheny Ahmed El Taweel Mokhtar R. Gomaa Mahmoud Shehata Marawan A. Elbaset Ahmed E. Kayed Sara H. Mahmoud Yassmin Moatasim Omnia Kutkat Noha N. Yassen Marwa E. Shabana Mohamed GabAllah Mina Nabil Kamel Noura M. Abo Shama Mohamed El Sayes Amira N. Ahmed Zahraa S. Elalfy Bassim MSA Mohamed Safa N. Abd El-Fattah Hazem Mohamed El Hariri Mona Abdel Kader Osama Azmy Ghazi Kayali Mohamed A. Ali |
| author_sort | Ahmed Kandeil |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T05:45:48Z |
| format | Article |
| id | doaj.art-16f183606c1f4285b2d3c5e5027ad362 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T05:45:48Z |
| publishDate | 2021-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-16f183606c1f4285b2d3c5e5027ad3622023-12-03T12:21:08ZengMDPI AGVaccines2076-393X2021-03-019321410.3390/vaccines9030214Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical StudiesAhmed Kandeil0Ahmed Mostafa1Rehab R. Hegazy2Rabeh El-Shesheny3Ahmed El Taweel4Mokhtar R. Gomaa5Mahmoud Shehata6Marawan A. Elbaset7Ahmed E. Kayed8Sara H. Mahmoud9Yassmin Moatasim10Omnia Kutkat11Noha N. Yassen12Marwa E. Shabana13Mohamed GabAllah14Mina Nabil Kamel15Noura M. Abo Shama16Mohamed El Sayes17Amira N. Ahmed18Zahraa S. Elalfy19Bassim MSA Mohamed20Safa N. Abd El-Fattah21Hazem Mohamed El Hariri22Mona Abdel Kader23Osama Azmy24Ghazi Kayali25Mohamed A. Ali26Center of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptDepartment of Pharmacology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptDepartment of Pharmacology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptDepartment of Pathology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptDepartment of Pathology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptCenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptDepartment of Clinical & Chemical Pathology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptDepartment of Pathology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptDepartment of Pharmacology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptDepartment of Clinical & Chemical Pathology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptDepartment of Community Medicine, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptDepartment of Clinical & Chemical Pathology, Medical Division, National Research Centre, Cairo, Giza 12622, EgyptReproductive Health Department, Medical Research Division, National Research Centre, Giza 12622, EgyptDepartment of Epidemiology, Human Genetics, and Environmental Sciences, University of Texas, Houston, TX 77030, USACenter of Scientific Excellence for Influenza Virus, Environmental Research Division, National Research Centre, Giza 12622, EgyptSince 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.https://www.mdpi.com/2076-393X/9/3/214SARS-CoV-2pre-clinical studyvaccine safetyimmunogenicityefficacy |
| spellingShingle | Ahmed Kandeil Ahmed Mostafa Rehab R. Hegazy Rabeh El-Shesheny Ahmed El Taweel Mokhtar R. Gomaa Mahmoud Shehata Marawan A. Elbaset Ahmed E. Kayed Sara H. Mahmoud Yassmin Moatasim Omnia Kutkat Noha N. Yassen Marwa E. Shabana Mohamed GabAllah Mina Nabil Kamel Noura M. Abo Shama Mohamed El Sayes Amira N. Ahmed Zahraa S. Elalfy Bassim MSA Mohamed Safa N. Abd El-Fattah Hazem Mohamed El Hariri Mona Abdel Kader Osama Azmy Ghazi Kayali Mohamed A. Ali Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies Vaccines SARS-CoV-2 pre-clinical study vaccine safety immunogenicity efficacy |
| 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 | SARS-CoV-2 pre-clinical study vaccine safety immunogenicity efficacy |
| url | https://www.mdpi.com/2076-393X/9/3/214 |
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