Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) .~Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μgNCP-RBD protein/0.5mL/bottle.~Indications: Prevention of respiratory diseases caused by new coronavirus infection .~Research population: healthy people aged 3 to 17 . Research Unit: Hunan Provincial Center for Disease Control and Prevention. Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17.~Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted.~Immunization program: 0, 1, and 2 months. Dose:25μg/0.5mL/bottle. Study population: 75 healthy people aged 3 to 17 years old, both male and female.~Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.~Research plan and implementation:According to the age from big to small, it was divided into three stages: 12 to 17 years old, 6 to 11 years old, 3 to 5 years old. The subjects of each age group were randomly divided into the experimental vaccine group and the placebo control group, 20 in the experimental vaccine group and 5 in the placebo group.~In the first stage, the subjects aged 12 to 17 years old were randomly divided into the experimental vaccine group (20 cases) and the placebo group (5 cases); The safety data of 0-7 days after the first dose were evaluated by the researchers. If the suspension / termination criteria were not met, the second phase of the study was carried out, and the subjects aged 6-11 years old in the trial vaccine group (20 cases) and placebo group (5 cases) were randomly enrolled; The safety data of subjects aged 6 to 17 years old from 0 to 7 days after the second dose of vaccine were evaluated by the researchers. If the suspension / termination criteria were not met, the third phase study was carried out, and the subjects aged 3 to 5 years old in the trial vaccine group (20 cases) and placebo group (5 cases) were randomly enrolled.~The subjects were followed up for 30 days after each dose. If the suspension / termination criteria were met, DSMB would decide whether to vaccinate the next dose; In other cases, it was up to the researchers to decide whether or not to receive the follow-up dose.~Safety endpoint:~1. The incidence of all AEs within 1 month after the first dose to the full course of vaccination:~Total AE incidence;~The incidence of AEs related to research vaccines;~The incidence of grade 3 and above AE;~The incidence of grade 3 and above AEs related to research vaccines;~The incidence of AEs leading to withdrawal;~The incidence of AEs related to research vaccines leading to withdrawal; 2. The incidence of all serious adverse events (SAE) and the incidence of SAE related to the vaccine within 12 months after the first dose to the full course of vaccination; 3. Changes in the clinical significance of the laboratory test indicators after first and second dose of inoculation compared to before the first dose.~Immunogenicity endpoint:~Humoral immunity: before the first dose of vaccination, 1 month,3 month and 6 months after the full vaccination, neutralizing antibodies of novel coronavirus (SARS-CoV-2), S protein binding antibody (IgG), RBD protein binding antibody (IgG) ) Positive rate; The levels of neutralizing antibodies against SARS-CoV-2, S protein binding antibody (IgG) and RBD protein binding antibody (IgG) and their relative immunity 1 month , 3 month and 6 months after the full vaccination of all subjects increase the multiple before.
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17.~Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted.~Study population: 75 healthy people aged 3 to 17 years old, both male and female.~Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.