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Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies

Authors :
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
Source :
Vaccines, Vol 9, Iss 3, p 214 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

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.

Details

Language :
English
ISSN :
2076393X
Volume :
9
Issue :
3
Database :
Directory of Open Access Journals
Journal :
Vaccines
Publication Type :
Academic Journal
Accession number :
edsdoj.16f183606c1f4285b2d3c5e5027ad362
Document Type :
article
Full Text :
https://doi.org/10.3390/vaccines9030214