phase i clinical trial of recombinant sars-cov-2 spike protein vaccine (cho cell) for the prevention of covid-19

Conditions: COVID-19

Summary: the purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity of 202-cov at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.


Eligibility criteria:
inclusion criteria: * healthy individuals aged 18-59 years as well as 60 years and above who can provide legal identification (males and females are both required). * willing to participate in the study with informed consent prior to screening * negative in sars-cov-2 igg and igm test at screening. * women of childbearing potential must be using effective method of birth control for 14 days prior to the enrollment of the study vaccine/placebo and must agree to continue such precautions during the study until 30 days after the second dose of the study vaccine/placebo. * male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 30 days after the second dose of the study vaccine/placebo. exclusion criteria: * confirmed or asymptomatic covid-19 cases or sars-cov-2 infection(had positive in sars-cov-2 nucleic acid test or serological test). * had a history of traveling or residence in domestic area of high and moderate pandemic risk, overseas or epidemic areas, or had a history of contact with confirmed, asymptomatic or suspected covid-19 cases within the past 14 days; * history of sars; * received sars-cov-2 vaccines for emergency use or approved sars-cov-2 vaccines; * individuals involving a clinical study within 6 months prior to the screening visit; or planning to participate in another clinical study during study period. * clinical laboratory abnormalities and with clinical significance judged by investigator * individual's systolic blood pressure ≥ 150mmhg and/or diastolic blood pressure ≥ 100mmhg at screening visit * axillary temperature \>=37.3℃ prior to vaccination * individuals in other acute diseases, or in the acute phase of chronic diseases within 3 days prior to the signing of the informed consent form. * received immunoglobulin and/or blood product 3 months prior to the first vaccination. * presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for sars-cov-2 infection and/or its complications as judged by the investigator.. * individuals with a history of severe allergic reaction (throat swelling, difficult in breath, dyspnea, or shock). * individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction \[e.g., anaphylaxis to any component of the study vaccines (s protein, aluminum hydroxide, cpg adjuvant). * any autoimmune or immunodeficiency disease/condition \[e.g. human immunodeficiency virus (hiv) infection, systemic lupus erythematosus (sle)\] * received immunoglobulin, blood-derived products within 3 months prior to the first study vaccination. * abnormal coagulation function (such as coagulation factor deficiency, coagulation disease, platelet abnormality) obvious bruises or coagulopathy. * pregnant women or breastfeeding women. * according to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.