The objective of the study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine.
The study is a randomized, double-blinded, active-controlled (Approved vaccine) Phase II clinical study. The study consists of 2 stages, Stage 1 and 2. In Stage 1, participants would randomly receive 2 doses of SCTV01C, SCTV01E, Sinopharm COVID-19 vaccine or mRNA vaccine on Day 0 and Day 28. Stage 1 is aimed to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants after the 2nd dose of vaccination with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine. Stage 2 will start on Day 180 and the participants will receive a 3rd dose of vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Stage 1: Geometric mean titers (GMT) of neutralizing antibody against Beta (B.1.351) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time frame: Day 56 after the study vaccination
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time frame: Day 56 after the study vaccination
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 56 (28 days after the 2nd dose of vaccination);
Time frame: Day 56 after the study vaccination
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time frame: Day 208 after the study vaccination
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time frame: Day 208 after the study vaccination
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 208 (28 days after the 3rd dose of vaccination);
Time frame: Day 208 after the study vaccination
Incidence and severity of solicited AEs within 7 days after each dose of vaccine (Day 0 to Day 7, Day 28 to Day 35, and Day 180 to Day 187).
Time frame: 7 days after each study vaccination
Stage 1: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time frame: Day 180 after the study vaccination
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Day 0; intramuscular injection
Day 28; intramuscular injection
Day 180; intramuscular injection
Day 0; intramuscular injection
Day 28; intramuscular injection
Day 180; intramuscular injection
Day 0; intramuscular injection
Day 28; intramuscular injection
Day 180; intramuscular injection
Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time frame: Day 180 after the study vaccination
Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 180 (before the injection of the 3rd dose of vaccination);
Time frame: Day 180 after the study vaccination
Stage 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 0, Day14, Day 28 and Day 42;
Time frame: Day 0, Day 14, Day 28 and Day 42 after the study vaccination
Stage 1: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 56;
Time frame: Day 56 after the study vaccination
Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time frame: Day 365 after the study vaccination
Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time frame: Day 365 after the study vaccination
Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 365 (185 days after the 3rd dose of vaccination);
Time frame: Day 365 after the study vaccination
Stage 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination);
Time frame: Day 180 (Before the injection of the 3rd dose of vaccination) and Day 194 (14 days after the 3rd dose of vaccination)
Stage 2: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 208;
Time frame: Day 208 after the study vaccination
Incidence and severity of unsolicited systemic AEs within 28 days after each dose of vaccine (Day 0 to Day 28, Day 28 to Day 56, and Day 180 to Day 208);
Time frame: 28 days after each study vaccination
Incidence and severity of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 365 days after the 1st dose of vaccination.
Time frame: Day 0 to Day 365 after the study vaccination