For Phase 1 only. Additional information will be provided when Phase 2 is implemented. This is a two-part phase I/II, single-center, observer-blind, randomized, controlled vaccine trial to evaluate the safety, reactogenicity, and immunogenicity of the recombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and 28 days as compared to Comirnaty®, and of a booster dose of ZR202a-CoV vaccine in healthy adults. Part 1: A total of 60 eligible subjects will be randomized in a 1:1:1 ratio into one of the three vaccine groups (ZR202-CoV, ZR202a-CoV, or Comirnaty®), receiving 2 doses vaccination at 28 days interval. To assess safety and preliminary immunogenicity profile after primary series vaccination at pre-defined time points during the study. The DSMB will review the safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing to Part 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
SARS-CoV-2 adjuvanted recombinant protein vaccine (prototype)
SARS-CoV-2 adjuvanted recombinant protein vaccine (variant)
Comirnaty® (Pfizer-BioNTech)
Center for Vaccine Development-Mali
Bamako, Mali
Percentage of subjects reporting solicited AEs within 7 days after each vaccination (Part 1)
Time frame: 7 days after the first or second vaccination
Percentage of subjects reporting unsolicited AEs within 28 days after each vaccination (Part 1)
Time frame: 28 days after the first or second vaccination
Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) 14 days post vaccination - (Part 1)
Time frame: Screening Visit, 14 days after the 1st and 2nd vaccinations at Day 14 and Day 42, and 28 days after both vaccinations at Day 28 and Day 56
Immunogenicity as assess for SARS-CoV-2 specific neutralizing antibodies titers 28 days after each vaccination as measured by neutralization assay
Time frame: Day 28 and Day 56
Percentages of subjects reporting SAEs, AESIs (including COVID-19), MAAEs
Time frame: From 1st vaccination until 6 months after the 2nd vaccination (Part 1)
Immunogenicity as assess for SARS-CoV-2-specific anti-S protein IgG binding antibodies 28 days after each vaccination as measured by ELISA.
Time frame: Day 28 and Day 56
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