| Eligibility |
Inclusion Criteria:
1. Healthy subjects aged 18 and over with full civil capacity who can provide vaccination
information proving that they have received two doses of Novel Coronavirus inactivated
vaccine (Vero cells) in the last 3-13 months;
2. Subjects voluntarily participate in the study, sign informed consent, provide valid
identification, understand and comply with the requirements of the study protocol;
3. Fertile men and women of reproductive age did not have sex from day 1 of the last
menstrual cycle to day 1 of the study, or did not have sex with an effective
contraceptive method and did not experience contraceptive failure (examples of
contraceptive failure include male condom rupture during sex).Subjects also agreed to
use effective contraception from the time of signing informed consent to 1 month after
trial vaccination.
Exclusion Criteria:
1. History of confirmed or asymptomatic coronavirus infection or positive nucleic acid
test of novel Coronavirus infection;
2. SARS virus history;
3. Fever caused by any reason (such as cold, local inflammation, tumor, rheumatic immune
disease, etc.) within 72 hours before enrollment, or armpit temperature =37.3? on the
day of enrollment;
4. history of severe allergic to any vaccine, or to test the vaccine's active ingredient,
any a kind of active ingredients, use of material in the production process, including
aluminum has a history of severe allergic, for example: the acute allergic reaction
and allergic shock, allergic laryngeal edema, thrombocytopenic purpura, allergic
purpura, difficulty breathing, angioneurotic oedema, etc;
5. Persons suffering from the following diseases:
? Patients with stroke and encephalitis in the acute stage, patients with
immune-related neurological diseases (such as myomyelitis, Guillanbarre syndrome,
demyelinating disease, myasthenia gravis, etc.) that are not controlled, patients with
epilepsy and severe mental illness, and patients with other neurological diseases that
are not controlled;
? Patients with acute respiratory infection, acute attack of chronic obstructive
pulmonary disease, acute attack of bronchial asthma or clinical uncontrolled stage,
acute stage of pleural disease, etc.;
? systolic blood pressure =90mmHg and/or diastolic blood pressure =60mmHg of unknown
cause;Hypertension treated with lifestyle adjustment and/or medication, systolic blood
pressure =160mmHg and/or diastolic blood pressure =100mmHg;Severe coronary heart
disease, arrhythmia, heart rate less than 60 beats/min or more than 100
beats/min;Serious heart valve disease, aortic dissection, venous thrombosis;Patients
with severe heart failure;Severe arrhythmia, or patients with acute coronary syndrome,
acute aortic syndrome, etc.;
? patients with acute pancreatitis, acute intestinal obstruction, acute hepatitis,
patients with gastrointestinal bleeding symptoms, active stage of inflammatory bowel
disease, active stage of chronic hepatitis, active stage of tuberculosis, etc.;
? Patients with acute urinary and reproductive system infection, patients with severe
kidney disease (uncontrolled acute and chronic nephritis, patients who are using
glucocorticoids, immunosuppressants or biological agents, patients with acute renal
insufficiency or chronic kidney disease stage 3 or more namely glomerular filtration
rate eGFR<60ml/min);
? Diabetes patients with acute complications (remunerative acidosis, hyperotonic
state, lactic acidosis) or with the above acute complications recovered less than 2
weeks;Fasting blood glucose > 13.9 mmol/L;Hypothyroidism TSH & GT;10 µ IU/L, with T3
and T4 lower than normal;Patients with uncontrolled hyperthyroidism or
hyperthyroidism;
? lymphoproliferative disease uncontrolled period, aplastic anemia not alleviated
period, primary immune thrombocytopenia (ITP) activity period, coagulation disease
uncontrolled period and other patients;
? Was immune system disease (systemic lupus erythematosus, rheumatoid arthritis,
ankylosing spondylitis, sjogren's syndrome, etc.) in active patients, patients with
congenital or acquired immunodeficiency, clear merge opportunistic infections or
malignant tumors uncontrolled HIV infection, patients with lymphoma, leukemia or
autoimmune inflammatory disease;
? Patients with malignant tumor undergoing chemotherapy, radiotherapy, and
immunotherapy before and after surgery;Patients with organ transplant status;
? Patients with acute stage of severe allergic rhinitis, acute and chronic eczema or
urticaria with obvious symptoms and signs, or patients with other skin symptoms;
? The absence of spleen or history of splenic surgery;
6. Receive immunomodulators within 6 months, such as immunosuppressive doses of
glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week);Or
monoclonal antibodies;Or thymosin;Or interferon;However, topical use (such as
ointments, eye drops, inhalants or nasal sprays) is allowed;
7. Have received blood or blood-related products, including immunoglobulin (including
rabies immunoglobulin and tetanus immunoglobulin), within 3 months prior to
experimental vaccine vaccination;Or planned use of the experimental vaccine within 1
month of vaccination;
8. For those who have received rabies vaccine and tetanus vaccine and have not completed
the course of vaccination, other subunit vaccines and inactivated vaccines shall be
injected within 14 days before the experimental vaccine inoculation, and other live
attenuated vaccines shall be injected within 30 days before the experimental vaccine
inoculation;
9. Women who are breastfeeding or pregnant (including women of childbearing age who have
positive urine pregnancy test) or who plan to have a pregnancy within 1 month of the
test vaccine or their partners;
10. Have participated in or are participating in other COVID-19 related clinical trials,
in addition to completing two doses of inactivated novel Coronavirus vaccine in the
past 3-13 months;
11. The Investigator believes that the subject has any disease or condition that may place
the subject at unacceptable risk;Subjects cannot meet the requirements of the
program;Conditions that interfere with the assessment of vaccine response.
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