Safety and potency of BIV1‐CovIran inactivated vaccine candidate for SARS‐CoV‐2: A preclinical study
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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 10 4 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.
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SciScore for 10.1101/2021.06.10.447951: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IACUC: Vaccine Preparation: Animal Studies: All experiments with animals (BALB/c mice, guinea pigs, rabbits, and macaques) were carried out in accordance with the approval of the animal ethics committee guidelines of the Ministry of Health and Medical Education (Tehran, Iran). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Experimental Models: Cell Lines Sentences Resources 16 After 4 passages, viral RNA was extracted from the clarified cell culture supernatant of infected Vero cells by RNA extraction kit (Rojetechnologies, Yazd, Iran), and converted to cDNA. Verosuggested: …SciScore for 10.1101/2021.06.10.447951: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IACUC: Vaccine Preparation: Animal Studies: All experiments with animals (BALB/c mice, guinea pigs, rabbits, and macaques) were carried out in accordance with the approval of the animal ethics committee guidelines of the Ministry of Health and Medical Education (Tehran, Iran). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Experimental Models: Cell Lines Sentences Resources 16 After 4 passages, viral RNA was extracted from the clarified cell culture supernatant of infected Vero cells by RNA extraction kit (Rojetechnologies, Yazd, Iran), and converted to cDNA. Verosuggested: CLS Cat# 605372/p622_VERO, RRID:CVCL_0059)Experimental Models: Organisms/Strains Sentences Resources Vaccine Preparation: Animal Studies: All experiments with animals (BALB/c mice, guinea pigs, rabbits, and macaques) were carried out in accordance with the approval of the animal ethics committee guidelines of the Ministry of Health and Medical Education (Tehran, Iran). BALB/csuggested: RRID:IMSR_ORNL:BALB/cRl)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- No funding statement was detected.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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