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.

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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