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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Group 2a | 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 2b | 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 2c | 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 2d | Experimental | Adult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28 |
|
| Elderly Group 2e |
| 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 |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 56 days |
| Geometric mean fold rise (GMFR) of serum IgG antibodies | GMFR of serum IgG antibodies from before vaccination to each subsequent time point | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From dose 1 through 28 days after the last dose |
| Percentage of participants reporting solicited AEs |
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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 2f | 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 of 202-CoV with CpG / alum adjuvant |
|
| 202-CoV standard dose | Biological | standard dose 202-CoV with CpG / alum adjuvant |
|
| Placebo | Biological | Normal saline solution |
|
Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance. |
| 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 | 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 | 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 | From dose 1 through 12 months after the last dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |