Development of the Inactivated QazCovid-in Vaccine: Protective Efficacy of the Vaccine in Syrian Hamsters
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Abstract
In March 2020, the first cases of the human coronavirus disease COVID-19 were registered in Kazakhstan. We isolated the SARS-CoV-2 virus from clinical materials from some of these patients. Subsequently, a whole virion inactivated candidate vaccine, QazCovid-in, was developed based on this virus. To develop the vaccine, a virus grown in Vero cell culture was used, which was inactivated with formaldehyde, purified, concentrated, sterilized by filtration, and then adsorbed on aluminum hydroxide gel particles. The formula virus and adjuvant in buffer saline solution were used as the vaccine. The safety and protective effectiveness of the developed vaccine were studied in Syrian hamsters. The results of the studies showed the absolute safety of the candidate vaccine in the Syrian hamsters. When studying the protective effectiveness, the developed vaccine with an immunizing dose of 5 μg/dose specific antigen protected animals from a wild homologous virus at a dose of 10 4 . 5 TCID 50 / mL. The candidate vaccine induced the formation of virus-neutralizing antibodies in vaccinated hamsters at titers of 3.3 ± 1.45 log2 to 7.25 ± 0.78 log2, and these antibodies were retained for 6 months (observation period) for the indicated titers. No viral replication was detected in vaccinated hamsters, protected against the development of acute pneumonia, and ensured 100% survival of the animals. Further, no replicative virus was isolated from the lungs of vaccinated animals. However, a virulent virus was isolated from the lungs of unvaccinated animals at relatively high titers, reaching 4.5 ± 0.7 log TCID 50 /mL. After challenge infection, 100% of unvaccinated hamsters showed clinical symptoms (stress state, passivity, tousled coat, decreased body temperature, and body weight, and the development of acute pneumonia), with 25 ± 5% dying. These findings pave the way for testing the candidate vaccine in clinical human trials.
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SciScore for 10.1101/2021.07.13.452175: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Euthanasia Agents: To evaluate the effectiveness of the candidate vaccine in intramuscular administration of animals, 3 (n=5), 5 (n=5), 7 (n=5), 9 (n=5), 12 (n=5) and 14 (n=5) days after the challenge infection, the animals were euthanized by Carbon dioxide inhalation using a standard two-cell kit AE0904.
Field Sample Permit: This study was performed in compliance with national and international laws and guidelines on animal handling, and the experimental protocol was approved by the Committee on the Ethics of Animal Experiments of the RIBSP of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan (permit number: KZ0520/013, KZ1120/014).
IACUC: This study …SciScore for 10.1101/2021.07.13.452175: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Euthanasia Agents: To evaluate the effectiveness of the candidate vaccine in intramuscular administration of animals, 3 (n=5), 5 (n=5), 7 (n=5), 9 (n=5), 12 (n=5) and 14 (n=5) days after the challenge infection, the animals were euthanized by Carbon dioxide inhalation using a standard two-cell kit AE0904.
Field Sample Permit: This study was performed in compliance with national and international laws and guidelines on animal handling, and the experimental protocol was approved by the Committee on the Ethics of Animal Experiments of the RIBSP of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan (permit number: KZ0520/013, KZ1120/014).
IACUC: This study was performed in compliance with national and international laws and guidelines on animal handling, and the experimental protocol was approved by the Committee on the Ethics of Animal Experiments of the RIBSP of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan (permit number: KZ0520/013, KZ1120/014).Sex as a biological variable not detected. Randomization Animals: The experiments used 100 of Syrian hamsters, randomly selected by randomization. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Experimental Models: Cell Lines Sentences Resources Preparation of the candidate vaccine: The virus was cultured in Vero cells (WHO, Lot No. CB0 or CB884) at a temperature of 37 °C for 48 hours, and then inactivated with formaldehyde (Sigma Aldrich) for 24 hours. Verosuggested: NoneSoftware and Algorithms Sentences Resources Statistics: Statistical analysis was performed using Graph Pad Prism 8.4.2 (GraphPad Software) to evaluate p-values for the overall experiment for vaccinated and control groups followed by the Student parametric test and the Wilcoxon-Mann-Whitney non-parametric test. Graph Pad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)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 did not find any issues relating to the usage of bar graphs.
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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