Clinical Study of Recombinant Novel Coronavirus Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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 .

Official Title
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A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years

Conditions
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Coronavirus

Intervention / Treatment
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* Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group
* Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group
* Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons with full civil capacity aged 18-59 years (both included); The subjects themselves voluntarily agreed to participate in the study, and signed an informed consent form, and can provide valid identification; understand and comply with the requirements of the trial protocol; Body temperature under armpit <37.3℃; Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study. Exclusion Criteria: The vital signs and physical examination results of the population specified in the plan have clinical significance as determined by the clinician; A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, vascular neuropathy Edema, etc.; or any previous history of serious side effects after using any vaccine or drug; Those with a history of SARS and SARS-CoV-2 (meet any of the following: ① previous history of SARS and SARS-CoV-2 infection or morbidity; ② during the current SARS-CoV-2 epidemic, there are patients diagnosed/suspected with the new crown Contact history); Have taken antipyretics or painkillers within 24 hours before the first dose of vaccination; Within 14 days before the first dose of vaccination, subunit vaccines, inactivated vaccines, and live attenuated vaccines within 30 days; People with the following diseases: Acute febrile disease; Digestive diseases (eg, diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Congenital or Acquired immunodeficiency or a history of autoimmune diseases or treatment with immunomodulators within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; however, topical medications (such as ointment, eye drops, Inhalation or nasal spray); known to be diagnosed with infectious diseases, such as: patients with tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV positive or syphilis specific antibody positive; neurological disease or Neurodevelopmental dysplasia (eg, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis); history of psychiatric illness or family History; functional spleenlessness, and spleenlessness or splenectomy for any reason; severe chronic disease or disease in progress that cannot be controlled smoothly, such as diabetes, thyroid disease; severe liver and kidney disease; respiratory tract that currently requires daily medication Diseases (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment that exacerbates respiratory diseases (eg, asthma exacerbations) within the last 5 years; has severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, Ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or a history of myocarditis or pericarditis; with thrombocytopenia, any coagulopathy, or treatment with anticoagulants; tumor patients; Have received blood or blood-related products, including immunoglobulin, within 3 months; or plan to use it during the study; Women who are breastfeeding or pregnant (including a positive urine pregnancy test); Have used any research or unregistered product (medicine, vaccine, biological product or device) other than the research product within 3 months, or plan to use it during the research; The researchers believe that 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Population I<br>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. | Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group<br>* Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).<br>|
| Experimental: Population II<br>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. | Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group<br>* Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).<br>|
| Placebo Comparator: Population Ⅲ<br>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. | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group<br>* Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).<br>|
| Experimental: Population Ⅳ<br>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. | Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group<br>* Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).<br>|
| Experimental: Population Ⅴ<br>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. | Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group<br>* Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).<br>|
| Placebo Comparator: Population Ⅵ<br>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. | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group<br>* Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NOVID-19