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Published on: May 2, 2011
Safety and potency of BIV1-CovIran inactivated vaccine candidate for SARS-CoV-2: A preclinical study
Asghar Abdoli1,2, Reza Aalizadeh3, Hossein Aminianfar4
1Department of Hepatitis and AIDS, Pasteur Institute of Iran, Tehran, Iran.
Abstract:
The development of effective and safe COVID-19 vaccines is a major move forward in our global effort to control the SARS-CoV-2 pandemic. The aims of this study were (1) to develop an inactivated whole-virus SARS-CoV-2 candidate vaccine named BIV1-CovIran and (2) to determine the safety and potency of BIV1-CovIran inactivated vaccine candidate against SARS-CoV-2. Infectious virus was isolated from nasopharyngeal swab specimen and propagated in Vero cells with clear cytopathic effects in a biosafety level-3 facility using the World Health Organization's laboratory biosafety guidance related to COVID-19. After characterisation of viral seed stocks, the virus working seed was scaled-up in Vero cells. After chemical inactivation and purification, it was formulated with alum adjuvant. Finally, different animal species were used to determine the toxicity and immunogenicity of the vaccine candidate. The study showed the safety profile in studied animals including guinea pig, rabbit, mice and monkeys. Immunisation at two different doses (3 or 5 μg per dose) elicited a high level of SARS-CoV-2 specific and neutralising antibodies in mice, rabbits and nonhuman primates. Rhesus macaques were immunised with the two-dose schedule of 5 or 3 μg of the BIV1-CovIran vaccine and showed highly efficient protection against 104 TCID50 of SARS-CoV-2 intratracheal challenge compared with the control group. These results highlight the BIV1-CovIran vaccine as a potential candidate to induce a strong and potent immune response that may be a promising and feasible vaccine to protect against SARS-CoV-2 infection.
Insights
The BIV1-CovIran vaccine, an inactivated whole-virus candidate, demonstrated safety and potency against SARS-CoV-2 in animal studies. It successfully induced high levels of neutralizing antibodies and protected rhesus macaques from infection.
Area of Science:
- Virology
- Vaccinology
- Immunology
Background:
- The COVID-19 pandemic necessitates the development of safe and effective vaccines.
- Controlling SARS-CoV-2 transmission requires robust vaccine candidates.
Purpose of the Study:
- To develop an inactivated whole-virus SARS-CoV-2 vaccine candidate, BIV1-CovIran.
- To evaluate the safety and potency of the BIV1-CovIran vaccine in animal models.
Main Methods:
- SARS-CoV-2 was isolated, propagated in Vero cells, chemically inactivated, and purified.
- The vaccine was formulated with alum adjuvant and tested for toxicity and immunogenicity in guinea pigs, rabbits, mice, and monkeys.
- Rhesus macaques received two doses and were challenged with SARS-CoV-2.
Main Results:
- BIV1-CovIran showed a favorable safety profile across all tested animal species.
- Immunization with 3 or 5 μg doses induced significant SARS-CoV-2 specific and neutralizing antibodies in mice, rabbits, and nonhuman primates.
- Vaccinated rhesus macaques exhibited high protection against a SARS-CoV-2 intratracheal challenge.
Conclusions:
- BIV1-CovIran is a promising vaccine candidate with the potential to elicit a strong immune response.
- The inactivated whole-virus vaccine demonstrated feasibility and efficacy in preclinical evaluations.
- Further development of BIV1-CovIran could contribute to global COVID-19 control efforts.
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