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A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the 3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0, 1, 2 month immunization program .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population I | Experimental | In population I, there were 150 subjects who injected with 2 doses of low-dose test vaccine into the deltoid muscle of the upper arm according to the 0 and 1 month immunization schedule. |
|
| Population II | Experimental | In population II, there were 150 subjects who injected with 2 doses of high-dose test vaccine in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule. |
|
| Population Ⅲ | Placebo Comparator | In population Ⅲ, there were 150 subjects who injected with 2 doses of placebo in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule. |
|
| Population Ⅳ | Experimental | In population Ⅳ, there were 150 subjects who injected with 3 doses of low-dose test vaccine in the upper arm deltoid muscle according to the 0, 1, and 2 month immunization schedule. |
|
| Population Ⅴ | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant new coronavirus vaccine (CHO cell) low-dose group | Biological | Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody positive conversion rate | Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination | 30 days after inoculation |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody GMT, positive rate | GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people | 14 days after inoculation |
| Neutralizing antibody GMT, positive conversion rate/positive rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center for Disease Control and Prevention | Hunan | Changsha | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33773111 | Derived | Yang S, Li Y, Dai L, Wang J, He P, Li C, Fang X, Wang C, Zhao X, Huang E, Wu C, Zhong Z, Wang F, Duan X, Tian S, Wu L, Liu Y, Luo Y, Chen Z, Li F, Li J, Yu X, Ren H, Liu L, Meng S, Yan J, Hu Z, Gao L, Gao GF. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infect Dis. 2021 Aug;21(8):1107-1119. doi: 10.1016/S1473-3099(21)00127-4. Epub 2021 Mar 24. |
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In population Ⅴ, there were 150 subjects who injected with 3 doses of high-dose test vaccine into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months. |
|
| Population Ⅵ | Placebo Comparator | In Population Ⅵ, there were 150 subjects who injected with 3 doses of placebo into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months. |
|
| Recombinant new coronavirus vaccine (CHO cells) high-dose group | Biological | Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). |
|
| Recombinant new coronavirus vaccine (CHO cells) placebo group | Biological | Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). |
|
GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population
| 14 days after inoculation |
| Neutralizing antibody GMT | Neutralizing antibody GMT 30 days after vaccination in pre-negative people | 30 days after inoculation |
| Neutralizing antibody GMT | Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination | 6th and 12th month after inoculation |
| Neutralizing antibody GMI, positive rate | Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination | 6th and 12th month after inoculation |
| IL-2, IL-4, IL-5, IL-6 and IFN-γ levels | Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination | 4th day and 12 months after inoculation |
| Adverse events | Adverse events 30 days after the first dose of vaccine to the entire exemption | 30 days after inoculation |
| Serious adverse event | Serious adverse events from day 0 after vaccination to 12 months after the entire immunization | 12 months after inoculation |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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