Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) 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. 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.
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.
Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
standard constrain：
1. Persons with full capacity for civil conduct aged ≥60 years;
2. Subjects voluntarily agree to participate in the research and sign an informed consent
form, and can provide valid identification; understand and comply with the
requirements of the trial protocol; have the ability to understand (non-illiterate)
research procedures and participate in the planned follow-up;
3. Axillary body temperature <37.3℃;
4. Female subjects and male subjects of childbearing age agree to take effective
contraceptive measures during the study period.
Exclusion criteria：
1. The results of physical examination and laboratory examination before screening are
abnormal and clinically significant as judged by clinicians, or systolic blood
pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg before screening;
2. A history of severe allergies to any component of the test vaccine, including aluminum
preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura,
thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, blood
vessels Neuroedema, etc.; or any previous history of serious side effects after the
use of any vaccine or drug;
3. People with a history of SARS and SARS-CoV-2 (meet any of the following: ①Have a
history of SARS and SARS-CoV-2 infection or onset; ②During this SRAS-CoV-2 epidemic,
there are patients who have been diagnosed with the new crown/ Suspected patient
contact history);
4. Have taken antipyretic or analgesic within 24 hours before the first dose of
vaccination;
5. Inoculate subunit vaccine and/or inactivated vaccine within 14 days before the first
dose of vaccine, and inoculate live attenuated vaccine within 30 days;
6. People suffering from the following diseases:
- Acute (within 72 hours) feverish illness;
- Suffering from digestive system diseases (such as diarrhea, abdominal pain,
vomiting, etc.) in the past 7 days;
- Suffering from congenital malformations or developmental disorders,
genetic defects, severe malnutrition, etc.;
- Congenital or acquired immunodeficiency or autoimmune disease
history or receiving immunomodulator treatment within 6 months,
such as hormones; or monoclonal antibodies; or thymosin; or
interferon, etc.; but local medication (such as ointment, Eye
drops, inhalation or nasal spray);
- Known to have been diagnosed with infectious diseases, such
as: tuberculosis, viral hepatitis and/or human
immunodeficiency virus HIV antibody positive or syphilis
specific antibody positive;
- Neurological diseases or neurodevelopmental dysfunction
(for example, migraine, epilepsy, stroke, seizures in
the last three years, encephalopathy, focal neurological
deficits, Guillain-Barré syndrome, encephalomyelitis or
transverse myelitis; History of mental illness or family
history;
⑦Functional asplenia, as well as any cause of aspleen or
splenectomy;
⑧Severe chronic diseases or conditions that cannot be
controlled smoothly in the advanced stage, such as
diabetes and thyroid disease;
⑨Severe liver and kidney diseases; respiratory diseases
that currently require daily drug treatment (for
example, chronic obstructive pulmonary disease [COPD],
asthma) or any treatment for exacerbation of respiratory
diseases (for example, asthma exacerbation) in the last
5 years; suffering from severe History of cardiovascular
disease (such as congestive heart failure,
cardiomyopathy, ischemic heart disease, arrhythmia,
conduction block, myocardial infarction, pulmonary heart
disease) or myocarditis or pericarditis;
⑩Have thrombocytopenia, any coagulation dysfunction or
receive anticoagulant treatment, etc.;
?Tumor patients;
7. Have received blood or blood-related products, including immunoglobulin, within 3
months; or plan to use it during the research period;
8. Those who are already pregnant (including a positive urine pregnancy test), or are
breastfeeding;
9. Any research or unregistered products (drugs, vaccines, biological products or
devices) other than research products have been used within 3 months, or planned to be
used during the research period;
10. The investigator believes that any disease or condition in the subject may put the
subject at an unacceptable risk; the subject cannot meet the requirements of the
protocol; it interferes with the assessment of the vaccine response.
Hunan Provincial Center for Disease Control and Prevention
Xiangtan, Changsha, China