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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Beijing Chao Yang Hospital | OTHER |
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In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose . The researchers conducted a safety evaluation and agreed to follow-up after discharge.
In this trial, all adverse events (AE), all AEs from 0-7 days, and all AEs from 8-30 days will be collected 30 minutes after each dose, and all AEs will be collected from the first dose to 30 days after the entire vaccination, and the first dose will be inoculated to the full course All serious adverse events (SAE) 6 months after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population I | Experimental | Population I has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population I is intramuscular injection of deltoid muscle of upper arm with low dose of vaccine. |
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| Population II | Experimental | Population II has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population II is a high-dose vaccine intramuscular injection of deltoid muscle of the upper arm. |
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| Population Ⅲ | Placebo Comparator | Population Ⅲ has 10 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is a placebo intramuscular injection of deltoid muscle of the upper arm. |
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| 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 |
|---|---|---|
| The number of adverse events after intramuscular injection | The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site, vital signs, blood routine, blood biochemistry, and urine routine. | Up to one year after the last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenic end point | All subjects The levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ levels before each vaccination, day 14 after the first vaccination, day 7 after the second vaccination, and 1 and 6 months after the entire vaccination. All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Positive rate of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG). All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Titer level and its multiplier than before exemption of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG). |
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Inclusion Criteria:
Exclusion Criteria:
The vital signs, physical examination and laboratory test indicators of the population specified in the plan are abnormal and have clinical significance as determined by the clinician;
Have a history of severe allergies to any component of the research vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction); or any previous History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin eczema, dyspnea, angioedema, etc .
Those with a history of SARS and COVID-19, meet any of the following:
Have taken antipyretics or painkillers within 24 hours before the first dose of vaccine.
Inoculate subunit vaccine and inactivated vaccine within 14 days before the first dose of vaccination, and inoculate live attenuated vaccine within 30 days.
People with the following diseases:
Lactating women or pregnant women (including blood or urine pregnancy test positive).
Any research or unregistered product (medicine, vaccine, biological product or device) other than the research product was used within 3 months before the application of the test drug / vaccine, or planned to be used during the study.
People with halo and halo needles.
The investigator believes that the presence of any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the protocol requirements; and interfere with the assessment of vaccine response.
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| Name | Affiliation | Role |
|---|---|---|
| Hong Ren, master | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | 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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| 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). |
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| 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). |
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| Within 6 months after the last dose of vaccination |
| 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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