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| Name | Class |
|---|---|
| 307 Hospital of PLA | OTHER |
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This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 480 in total.
Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle-dose vaccine (18-59 years) | Experimental | Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56 |
|
| High-dose vaccine (18-59 years) | Experimental | Two doses of High-dose vaccine at the schedule of day 0, 28, 56 |
|
| Middle-dose vaccine (60-85 years) | Experimental | Three doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56 |
|
| High-dose vaccine (60-85 years) | Experimental | Two doses of High-dose experimental vaccine at the schedule of day 0, 28, 56 |
|
| Middle-dose placebo (18-59 years) | Placebo Comparator | Three doses of middle-dose placebo at the schedule of day 0, 28, 56 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56 | Biological | 18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. |
| Measure | Description | Time Frame |
|---|---|---|
| The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays) | 30 days after full-course vaccination in each study group | |
| The incidence of adverse reaction (AR) | 0 to 7 days after vaccination in each study group |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE) | 0 to 30 days after vaccination in each study group | |
| The incidence of severe adverse events (SAE) | 12 months after prime and boost vaccination | |
| Measure | Description | Time Frame |
|---|---|---|
| The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups | 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group | |
| Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria of subsequent dose:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanyue Meng, Doctor | Contact | 18915999245 | mfy19780712@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, Doctor | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Recruiting | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36103390 | Derived | Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016. |
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| High-dose placebo (18-59 years) | Placebo Comparator | Two doses of High-dose placebo at the schedule of day 0, 28, 56 |
|
| Middle-dose placebo (60-85 years) | Placebo Comparator | Three doses of middle-dose placebo at the schedule of day 0, 28, 56 |
|
| High-dose placebo (60-85 years) | Placebo Comparator | Two doses of High-dose placebo at the schedule of day 0, 28, 56 |
|
| a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56 | Biological | 18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. |
|
| a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56 | Biological | 60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. |
|
| a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56 | Biological | 60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56. |
|
| a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56 | Biological | 18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56. |
|
| a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56 | Biological | 18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56. |
|
| a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56 | Biological | 60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56. |
|
| a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56 | Biological | 60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56. |
|
| The Geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays) |
| 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group |
| The Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays) | 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group |
| The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays) | 14 days, 6 months and 12 months after full-course vaccination in each study group |
| The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (pseudovirus neutralization assays) | 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group |
| The positive conversion rate of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody | 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group |
| The GMT of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody | 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group |
| The GMI of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody | 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group |
| 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group |
| The proportion of IFN-γ secreted by T cells at Day 14 using ELISpot detection method | Day 14 after full-course vaccination in each study group |
| The Intracellular cytokine staining (ICS)/flow cytometry was used to detect the Th1/Th2 immune response after immunization (CD3+/CD4+/CD8+ T cells, and cytokines TNFα/IFNγ/IL2/IL4). | Day 14 after full-course vaccination in each study group |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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