The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
72
standard dose of 202-CoV with low dose CpG / alum adjuvant
low dose 202-CoV with CpG / alum adjuvant
standard dose 202-CoV with CpG / alum adjuvant
Xiangcheng Center for Disease Control and Prevention
Xuchang, China
Incidence of solicited adverse events (AEs) after vaccination
Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance.
Time frame: 7 days after the first or second vaccination
Incidence of unsolicited AEs after vaccination
Percentage of participants with unsolicited AEs for 28 days following each vaccination
Time frame: Frame: Day 0 to Day 56
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
Percentage of participants with SAEs or AESI for 12month after last dose vaccination
Time frame: Day 0 to Month 13
Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters
Safety Laboratory Values (Serum Chemistry, Hematology)
Time frame: Day 4 after first or second vaccination
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies
Neutralizing antibody activity as detected by neutralization assay expressed as GMTs at multiple time points through Day 56
Time frame: Day0, Day28, Day42 and Day56
Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies
Neutralizing antibody activity as detected by neutralization assay expressed as seroconversion rate at multiple time points through Day 56
Time frame: Day0, Day28, Day42 and Day56
Geometric mean titer (GMT) of Serum IgG Antibody Levels
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Normal saline solution
Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as GMTs at multiple time points through Day 56
Time frame: Day0, Day28, Day42 and Day56
Seroconversion rate (SCR) of Serum IgG Antibody Levels
Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as seroconversion rate at multiple time points through Day 56
Time frame: Day0, Day28, Day42 and Day56