The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E compared with Comirnaty.
Approximately 400 participants aged ≥18 years old and previously vaccinated with 2 or 3 doses of Comirnaty will be enrolled in this study. They will be randomly assigned to SCTV01E Group and Comirnaty Group in a ratio of 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
400
Geometric mean titers (GMT) of neutralizing antibodies (nAb) to Omicron variant on Day 28
Time frame: day 28 sfter the study vaccination
GMT of nAb to variant Delta on Day 28
Time frame: day 28 sfter the study vaccination
GMT of nAb to Alpha variant on Day 28
Time frame: day 28 sfter the study vaccination
GMT of nAb to Beta variant on Day 28
Time frame: day 28 sfter the study vaccination
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28.
Time frame: day 28 sfter the study vaccination
Seroresponse rates of nAb to Omicron variant on D28
Seroresponse is defined as a change from below the low limit of quantitation \[LLOQ\] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline
Time frame: day 28 after the study vaccination
Seroresponse rates of nAb to Delta variant on D28
Seroresponse is defined as a change from below the low limit of quantitation \[LLOQ\] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline
Time frame: day 28 after the study vaccination
Seroresponse rates of nAb to Alpha variant on D28
Seroresponse is defined as a change from below the low limit of quantitation \[LLOQ\] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline
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Time frame: day 28 after the study vaccination
Seroresponse rates of nAb to Beta variant on D28
Seroresponse is defined as a change from below the low limit of quantitation \[LLOQ\] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline
Time frame: day 28 after the study vaccination
Incidence and severity of solicited AEs from Day 0 to Day 7 after the study vaccination
Time frame: day 0 to day 7 after the study vaccination
Incidence and severity of unsolicited AEs from Day 0 to Day 28 after the study vaccination
Time frame: day 0 to day 28 after the study vaccination
Incidence and severity of SAEs and AESIs within 180 days after study vaccination
Time frame: day 0 to day 180 after the study vaccination