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.

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.