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| Name | Class |
|---|---|
| Walvax Biotechnology Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Group 1a | Experimental | Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low adjuvant dose at Day 0 and Day 28 |
|
| Adult Group 1b | Experimental | Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low antigen dose at Day 0 and Day 28 |
|
| Adult Group 1c | Experimental | Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV standard dose at Day 0 and Day 28 |
|
| Adult Placebo | Placebo Comparator | Adult healthy subjects (18 to 59 years of age, inclusive) receive 2 doses of placebo (saline) at Day 0 and Day 28 |
|
| Elderly Group 1d | Experimental | Adult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28 |
|
| Elderly Group 1e |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 202-CoV low adjuvant dose | Biological | standard dose of 202-CoV with low dose CpG / alum adjuvant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Frame: Day 0 to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 to Month 13 |
| Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangcheng Center for Disease Control and Prevention | Xuchang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34750014 | Derived | Liu H, Zhou C, An J, Song Y, Yu P, Li J, Gu C, Hu D, Jiang Y, Zhang L, Huang C, Zhang C, Yang Y, Zhu Q, Wang D, Liu Y, Miao C, Cao X, Ding L, Zhu Y, Zhu H, Bao L, Zhou L, Yan H, Fan J, Xu J, Hu Z, Xie Y, Liu J, Liu G. Development of recombinant COVID-19 vaccine based on CHO-produced, prefusion spike trimer and alum/CpG adjuvants. Vaccine. 2021 Nov 26;39(48):7001-7011. doi: 10.1016/j.vaccine.2021.10.066. Epub 2021 Oct 30. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Experimental |
Adult healthy subjects (60 years of age and above) receive 202-CoV low antigen dose at Day 0 and Day 28 |
|
| Elderly Group 1f | Experimental | Adult healthy subjects (60 years of age and above) receive 202-CoV standard dose at Day 0 and Day 28 |
|
| Elderly Placebo | Placebo Comparator | Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28 |
|
| 202-CoV low antigen dose | Biological | low dose 202-CoV with CpG / alum adjuvant |
|
| 202-CoV standard dose | Biological | standard dose 202-CoV with CpG / alum adjuvant |
|
| Placebo | Other | Normal saline solution |
|
Safety Laboratory Values (Serum Chemistry, Hematology) |
| 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 | 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 | Day0, Day28, Day42 and Day56 |
| Geometric mean titer (GMT) of Serum IgG Antibody Levels | 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 | 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 | Day0, Day28, Day42 and Day56 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |