SpiN-Tec MCTI UFMG will be used as a vaccine booster against COVID-19 and will be evaluated using the active comparator, a vaccine approved by ANVISA (Brazilian Health Regulatory Agency). The study will consist of two parts: Part A) a Phase 1 dose-escalation clinical trial to assess safety and reactogenicity; followed by Part B) a Phase 2 clinical trial to assess the safety and immunogenicity of SpiN-Tec. The study will include healthy participants of both sexes, aged 18 to 85, who have already received the full COVID-19 vaccination schedule with CoronaVac® (Butantan) or Covishield® (AstraZeneca) and who have received one or two booster doses of Covishield® or Comirnaty® (Pfizer's RNA-based vaccine) at least 6 months ago. Participants may or may not have had natural SARS-CoV-2 infection.
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Parts A, A2 e B: safety and reactogenicity for EAG and EAIE
Timeframe: In the first 28 days to EAG and EAIE for the entire duration of the study after immunization
Part A: define a safe and immunogenic dose of SpiN-Tec MCTI UFMG to be used in Part B
Timeframe: At the end of visit V28 of the last randomized participant in Part A
Parte B: prove the non-inferiority of SpiN-Tec MCTI UFMG in inducing neutralizing antibodies
Timeframe: On day 28 after the booster of the SpiN-Tec MCTI UFMG vaccine