PT - JOURNAL ARTICLE AU - Abdoli, Asghar AU - Aalizadeh, Reza AU - Aminianfar, Hossein AU - Kianmehr, Zahra AU - Azimi, Ebrahim AU - Emamipour, Nabbi AU - Jamshidi, Hamidreza AU - Hosseinpour, Mohammadreza AU - Taqavian, Mohammad AU - Jalili, Hasan TI - Safety and Potency of COVIran Barekat Inactivated Vaccine Candidate for SARS-CoV-2: A Preclinical Study AID - 10.1101/2021.06.10.447951 DP - 2021 Jan 01 TA - bioRxiv PG - 2021.06.10.447951 4099 - http://biorxiv.org/content/early/2021/06/10/2021.06.10.447951.short 4100 - http://biorxiv.org/content/early/2021/06/10/2021.06.10.447951.full AB - There is an urgent demand to manufacture an effective and safe vaccine to prevent SARS-CoV2 infection, which resulted in a global pandemic. In this study, we developed an inactivated whole-virus SARS-CoV-2 candidate vaccine named COVIran Barekat. Immunization at two different doses (3 µg or 5 µg per dose) elicited a high level of SARS-CoV-2 specific neutralizing antibodies in mice, rabbits, and non-human primates. The results show the safety profile in studied animals (include guinea pig, rabbit, mice, and monkeys). Rhesus macaques were immunized with the two-dose of 5 µg and 3 µg of the COVIran Barekat vaccine and showed highly efficient protection against 104 TCID50 of SARS-CoV-2 intratracheal challenge compared with the control group. These results highlight the COVIran Barekat vaccine as a potential candidate to induce a strong and potent immune response which may be a promising and feasible vaccine to protect against SARS-CoV2 infection.Competing Interest StatementThe authors have declared no competing interest.