Coronavirus
Conditions
Keywords
NOVID-19
Brief summary
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
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 .
Interventions
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Sponsors
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody positive conversion rate | 30 days after inoculation | Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody GMT, positive conversion rate/positive rate | 14 days after inoculation | GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population |
| Neutralizing antibody GMT | 30 days after inoculation | Neutralizing antibody GMT 30 days after vaccination in pre-negative people |
| Neutralizing antibody GMI, positive rate | 6th and 12th month after inoculation | Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination |
| Neutralizing antibody GMT, positive rate | 14 days after inoculation | GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people |
| Adverse events | 30 days after inoculation | Adverse events 30 days after the first dose of vaccine to the entire exemption |
| Serious adverse event | 12 months after inoculation | Serious adverse events from day 0 after vaccination to 12 months after the entire immunization |
| IL-2, IL-4, IL-5, IL-6 and IFN-γ levels | 4th day and 12 months after inoculation | Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination |
Countries
China
Outcome results
None listed