clinical trial of recombinant covid-19 vaccine (sf9 cells) in children and adolescents

Conditions: COVID-19

Summary: this is a phase ⅰ/ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant covid-19 vaccine (sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).

this is a phase ⅰ/ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant covid-19 vaccine (sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg). the phase ⅰ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): each group including 30 participants. vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 120 in total. the phase ⅱ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): each group including 120 participants. vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 480 in total.

Eligibility criteria:
inclusion criteria: * aged 6-17 years； * the subject and/or guardian can understand and voluntarily sign the informed consent form (double signature is required for 8-17 years old)； * reproductive women have a negative pregnancy test before each vaccination； * the subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 13.5 months. exclusion criteria: * history of sars-cov-2 infection. * the covid-19 antibody (igg and igm) screening was positive. * history of asthma, history of allergy to vaccines or vaccine components, or severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema. * congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * autoimmune diseases or immunodeficiency/immunosuppression. * severe chronic diseases that cannot be controlled by drugs, severe cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc. * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness. * any condition caused by thyroid disease or history of thyroidectomy, hypersplenism, or splenectomy. * diagnosis of abnormal blood clotting function (for example, lack of clotting factors, coagulopathy, abnormal platelets) or obvious bruising or blood clotting. * in the past 6 months, received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis). * laboratory test results with clinically significant abnormalities (severity level 2 and above) (applicable to phase i clinical trials only). * received blood products in the last 3 months. * receive other study drugs or vaccines within the past 30 days. * vaccination against live attenuated vaccines in the past 30 days. * inactivated vaccine or subunit vaccine in the past 14 days. * acute disease or acute exacerbation of chronic disease in the last 7 days. * axillary temperature\> 37.0°c. * according to the judgment of the investigator, the subject has other factors that are not suitable for participating in the clinical trial. subsequent dose exclusion criteria: in this trial, the second/third dose of vaccination may be stopped in some cases. this includes allergic reactions, severe hypersensitivity reactions, or grade 3 or higher adverse reactions that cannot be tolerated after previous vaccination/placebo. if these reactions occur, the subject should not continue to receive the second/third vaccination.

Keywords: safety immunogenicity covid-19 vaccine recombinant vaccine