The objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.
The study is a randomized, double-blind, and approved vaccine-controlled Phase II booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with one dose of Sinopharm inactivated COVID-19 vaccine or one dose of Commirnaty as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations (1-dose of SCTV01C and 1-dose of SCTV01E, or 2-dose of SCTV01E, or 1-dose of Sinopharm inactivated COVID-19 vaccine and 1-dose of SCTV01E, 1-dose of Comirnaty and 1-dose of SCTV01E).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
400
Day 0; intramuscular injection
Day 0; intramuscular injection
Day 0; intramuscular injection
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 28.
Time frame: Day 28 after the study vaccination
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 28.
Time frame: Day 28 after the study vaccination
GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 208.
Time frame: Day 208 after the study vaccination
GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 208.
Time frame: Day 208 after the study vaccination
Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28 and Day 208.
Time frame: Day 28 and D208 after the study vaccination
Seroresponse rates of neutralizing antibodiesto Delta variant on Day 28.
Time frame: Day 28 after the study vaccination
Seroresponse rates of neutralizing antibodies to Omicron variant rates on Day 28.
Time frame: Day 28 after the study vaccination
Seroresponse rates of neutralizing antibodies to Delta variant on Day 208.
Time frame: Day 208 after the study vaccination
Seroresponse rates of neutralizing antibodies to Omicron variant on Day 208.
Time frame: Day 208 after the study vaccination
Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7 and Day 180 to Day 187.
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Day 0; intramuscular injection
Day 180; intramuscular injection
Time frame: Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination
Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28 and Day 180 to Day 208.
Time frame: Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination
Incidence and severity of SAEs and AESIs of SCTV01C within 365 days.
Time frame: Day 0 to Day 365 after the 1st study vaccination
Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7 and Day 180 to Day 187.
Time frame: Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination
Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28 and Day 180 to Day 208.
Time frame: Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination
Incidence and severity of SAEs and AESIs of SCTV01E within 365 days.
Time frame: Day 0 to Day 365 after the 1st study vaccination