The purpose of this double-blind, randomized, controlled study is to assess immunogenicity and safety 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
528
standard dose of 202-CoV with low dose CpG / alum adjuvant
low dose of 202-CoV with CpG / alum adjuvant
standard dose 202-CoV with CpG / alum adjuvant
Xiangcheng Center for Disease Control and Prevention
Xuchang, China
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: 56 days
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: 56 days
Geometric mean titer (GMT) of serum IgG antibodies
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: 56 days
Seroconversion rate (SCR) of serum IgG antibodies
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: 56 days
Geometric mean fold rise (GMFR) of SARS-CoV-2 neutralising antibodies
GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
Time frame: 56 days
Geometric mean fold rise (GMFR) of serum IgG antibodies
GMFR of serum IgG antibodies from before vaccination to each subsequent time point
Time frame: 56 days
Percentage of participants reporting adverse events (AEs)
Percentage of participants with solicited AEs (local, systemic) for 28 days following each primary vaccination (Days 0, 28) by intensity, relevance.
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Normal saline solution
Time frame: From dose 1 through 28 days after the last dose
Percentage of participants reporting solicited AEs
Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance.
Time frame: For 7 days after dose 1 and dose 2
Percentage of participants reporting unsolicited AEs
Percentage of participants with unsolicited AEs for 28 days following each vaccination
Time frame: From dose 1 through 28 days after the last dose
Percentage of participants reporting serious adverse events (SAEs)
Percentage of participants with SAEs from dose 1 through 12month after last dose vaccination
Time frame: From dose 1 through 12 months after the last dose
Percentage of participants reporting adverse events of special interest (AESIs)
Percentage of participants with AESI from dose 1 through 12month after last dose vaccination
Time frame: From dose 1 through 12 months after the last dose