A multicenter, randomized, double-blind, active comparator, non-inferiority, multicenter IIb clinical trial to compare the safety and immunogenicity of two dose levels of the MCTI CIMATEC HDT RNA Vaccine against two authorized COVID-19 vaccines in Brazil (Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca) in 300 participants. Each vaccine will be provided as a single booster vaccine in adults aged 18 to 65 years previously immunized with both vaccines (Comirnaty - Pfizer and Covishield - Oxford/Astrazen). The investigational product MCTI C HDT will be administered in one of the two doses evaluated (5µg and 10 µg). The comparator products will be Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca. The primary outcomes will be the number of participants with a 2-fold increase or more on average by titers of neutralizing D64G pseudovirus strain (pNT50) and comparison of titers generated by 5µg and 10µg doses of MCTI-CIMATEC-HDT RNA Vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
300
Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer)
Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer and (Covishield - Oxford/Astrazen).
Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Non-inferiority)
Proportion of participants with a 2-fold or greater increase in geometric mean neutralizing antibody titers against D614G pseudovirus strain (pNT50).
Time frame: Day 29 after vaccination until day 181.
Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Dose determination)
Comparison of antibody titers generated by 5µg and 10µg doses of the MCTI-CIMATEC-HDT RNA Vaccine
Time frame: Day 29 after vaccination until day 181.
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