clinical study of recombinant novel coronavirus vaccine

Conditions: Coronavirus

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.

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 .

Eligibility criteria:
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.

Keywords: novid-19