A novel inactivated whole virion vaccine, QazCovid-in is developed to combat COVID-19. It is inactivated by formaldehyde, and adjuvanted with aluminum hydroxide. The total protein concentration is 5ug per dose of the vaccine. To analyze the safety and efficacy of the vaccine, the vaccine was administered in a one- or two-dose regimen on day 1 and day 21 in healthy individuals above 18 years without any COVID-19 history or contact. The participants were monitored for 6 months. No major adverse events (AEs) were reported in Phase 1 and 2 trials. In the phase 2 study, after the first dose, 77% of participants aged 18-49 years and 39% of 50-year-old participants reported mild local and systemic AEs after the first dose of the QazCovid-in vaccine. Local reactions were represented by transient (1-3 days) cases of pain, hyperemia, induration, and itch and pain at the injection site. There was a decrease in the frequency of AE after the second dose.
The immunological effects of the QazCovid-in vaccine was estimated in phase 1/2 clinical trials by the post-vaccination increase in virus-specific antibody titers. As per the phase 2 study, two doses are required to activate neutralizing antibodies. 59% of subjects demonstrated seroconversion after the first dose, and the number reached 100% after two doses of the vaccine. To characterize post-vaccination cellular immune response, the whole-blood cytokine release assay was used. . A statistically significant increase in the levels of pro-inflammatory cytokines after vaccination indicated the Th1-biased response.
Thus, the QazCovid-in vaccine is safe and well-tolerated among adults 18 to 70 years, who receive one or two doses. Single immunization has promoted the production of neutralizing antibodies with GMTs of 27 on day 21 which have not grown further, proving that the second vaccination is necessary.
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