Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2（COVID-19） Phase I Clinical Trial (3~17 Years Old)
Condition: Coronavirus
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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:

        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 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.
    

Intervention name(s): Recombinant new coronavirus vaccine (CHO cell) group; Recombinant new coronavirus vaccine (CHO cells) placebo group
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).; Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Recombinant Novel Coronavirus Vaccine