Popular topic:Clinical study on the immune program of recombinant Novel Coronavirus(COVID-19) vaccine (CHO cell). Research purpose:Main purpose: To evaluate theimmunogenicity of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6months or 0,1,4 months in persons aged 18 years and over. Secondary purpose: To evaluatethe safety of the investigational vaccine in people aged 18 and above.Overall design: In this study, recombinant novel coronavirus vaccine (CHO cells) isinoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluatethe immunogenicity and safety.Study population:The study involved people 18 years of age and older. Test groups:A totalof 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 agegroup. Three doses of experimental vaccine were administered according to the 0,1,6 monthimmunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (StudyNo. 151-300).
Overall design:In this study, recombinant novel coronavirus vaccine (CHO cells) is
inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate
the immunogenicity and safety.
Intervention: A total of 300 subjects were enrolled, including 221 in the 18-59 age group
and 79 in the ≥60 age group. Three doses of experimental vaccine were administered
according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months
immunization schedule (Study No. 151-300).
Immunogenicity observation:
About 5.0mL of venous blood was collected from all subjects for immunogenicity test
before the first dose, before the third dose, on day 14 and 180 after full immunization.
Safety observation:
All adverse events (AE) were collected within 30 minutes after each dose, all AEs (both
solicited and unsolicited) were collected 0-7 days after each dose, and all AEs
(unsolicited) were collected 8-30 days after each dose. All SAEs were collected from the
first dose up to 6 months after full immunization.
Solicited AEs (the following events occurring within 7 days of vaccination) :
Adverse events at the inoculation site (local) : pain, swelling, induration, redness,
rash, pruritus; Vital signs: fever; Non-inoculated site (systemic) adverse events:
headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute
allergic reaction, cough.
Vital signs and physical examination:
1. All subjects underwent a daily armpit temperature examination during the screening
period, before subsequent doses, and within 7 days after each dose.
2. All subjects underwent physical examination (skin and cardiopulmonary auscultation)
and blood pressure measurement during the screening period.
ADE/VED (Antibody Enhancement/vaccine Enhancement disease) Risk Monitoring:
After vaccination (at least one dose of experimental vaccine), if the subject is
diagnosed with COVID-19, he/she should go to the hospital for hospitalization or be
isolated in accordance with the epidemic prevention and control requirements of the area
in which he/she is located. A special investigation should be conducted for the existence
of ADE/VED in severe/critical cases/deaths.
Biological: Recombinant novel coronavirus vaccine (CHO cell)
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose
Recombinant novel coronavirus vaccine (CHO cells).
Inclusion Criteria:
1. Persons over the age of 18 with full capacity for civil conduct;
2. The subject voluntarily agrees to participate in the study and signs the informed
consent, and can provide valid identification, understand and comply with the
requirements of the study protocol;
3. Fertile male and female subjects of reproductive age agreed to use effective
contraceptive measures from the beginning of the study to 2 months after full
vaccination.
Exclusion Criteria:
1. Suspected or confirmed fever within 72 hours before enrollment, or armpit
temperature ≥37.3℃ on the day of enrollment;
2. Have a history of severe allergy to any component of the test vaccine, including
aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic
purpura, thrombocytopenic purpura, dyspnea, angiopantic edema, etc.; Or have a
history of severe adverse reactions to any of the above mentioned vaccines or
medications;
3. people who currently have or have a history of COVID-19;
4. Persons suffering from the following diseases:
① have thrombocytopenia, any coagulation dysfunction or receive anticoagulant
treatment, etc.;
② Congenital or acquired immune deficiency or autoimmune disease history or received
immunomodulatory treatment within 6 months Treatment, such as immunosuppressive
doses of glucocorticoid (dose reference: equivalent to prednisone 20mg/ day, more
than one weeks); Or monoclonal antibodies; Or thymosin; Or interferon; However,
topical application (e.g. ointments, eye drops) is allowed Liquid, inhalant or nasal
spray);
③ Have been diagnosed with a known infectious disease, such as active tuberculosis,
viral hepatitis, human immunodeficiency virus or treponema pallidum;
④ Neurological disorders (e.g., convulsions, migraines, epilepsy, stroke, epileptic
seizures in the last three years, encephalopathy, focal neurological deficits,
Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of
mental illness or family history;
⑤ functional absence of spleen, and absence of spleen or splenectomy caused by any
reason;
⑥ There are serious chronic diseases or diseases in the progressive stage can not be
controlled smoothly, such as diabetes, drugs can not control Hypertension (systolic
blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
⑦ Severe liver and kidney diseases; Any current respiratory illness requiring
routine medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or
any exacerbation of respiratory illness (e.g., exacerbation of asthma) within the
last 5 years; A history of serious cardiovascular disease (e.g., congestive heart
failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block,
myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;
⑧ Cancer patients (except basal cell carcinoma).
5. had taken an antipyretic or painkiller within 24 hours before the first dose of
vaccine;
6. Those who have received novel coronavirus vaccine, or subunit vaccine and/or
inactivated vaccine within 7 days before the first dose, or live attenuated vaccine
within 14 days;
7. Have received blood or blood-related products, including immunoglobulin, within 3
months; Or planned for use during the study period;
8. Lactating or pregnant women (including women of childbearing age who have positive
urine pregnancy test), or women who plan to have a pregnancy within 2 months after
full vaccination of the test vaccine or their partners;
9. Have participated in or are currently participating in other COVID-19 related
clinical trials;
10. 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.
Hunan Center for Disease Control and Prevention
Changsha, Hunan, China
Huang Tao, Principal Investigator
Hunan Provincial Center for Disease Control and Prevention