Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μg/0.5mL/bottle (low dose), 50μg/0.5mL/bottle (high dose) Indications: Prevention of respiratory diseases caused by new coronavirus infection Research population: healthy people ≥60 years old Research Unit: Hunan Provincial Center for Disease Control and Prevention Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).
Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.
Immunization program: 0, 1, and 2 months. Dose: Divided into low-dose group (25μg/0.5mL) and high-dose group (50μg/0.5mL).
Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.
Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
Research plan and implementation:Volunteers aged 60 and above signed the informed consent form and asked about medical history, residence history and other information and then performed relevant examinations, including height, weight, vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry), urine Pregnancy (women of childbearing age). After the study number is assigned, the subjects will collect throat swabs for SARS-CoV-2 real-time fluorescent RT-PCR nucleic acid detection, and blood will be collected for SARS-CoV-2 IgM and IgG antibody detection. Subjects will be in accordance with 0, 1, and 2 months Vaccination procedures are carried out. According to the order of the dose from low to high, it is divided into two stages and inoculated sequentially. Among them, placebo/five people per dose group, test vaccine/20 people per dose group, and qualified subjects were randomly enrolled into the test vaccine group and the placebo control group. In the first phase, subjects in the low-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled; the safety data of the first 7-day vaccination was evaluated by DSMB, and if the suspension/termination criteria were not met, the first In the second-phase study, subjects in the high-dose group (20 cases) and the placebo group (5 cases) were randomly enrolled. Follow-up to 30 days after each dose, if the suspension/termination criteria is reached, DSMB will decide whether to inoculate the follow-up doses; in other cases, the investigator will decide whether to inoculate the follow-up doses.
Safety endpoint:
1\. The incidence of all AEs within 1 month after the first dose to the full course of vaccination:
1. Total AE incidence;
2. The incidence of AEs related to research vaccines;
3. The incidence of grade 3 and above AE;
4. The incidence of grade 3 and above AEs related to research vaccines;
5. The incidence of AEs leading to withdrawal;
6. 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 each dose of inoculation compared to before the first dose.
Immunogenicity endpoint:
Humoral immunity: before the first dose of vaccination, 1 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 and 6 months after the full vaccination of all subjects Increase the multiple before.
