Prevention of novel coronavirus pneumonia
Conditions
Interventions
Random Cohort1:dose of test vaccine or positive control vaccine
Random Cohort2:dose of test vaccine or positive control vaccine
Random Cohort3:dose of test vaccine or positive control vaccine
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Chinese residents aged 18-59 who can provide legal identity certificates (including ID card, household register, medical insurance card and other valid documents); 2. At least 6 months after the completion of 2 doses of commercially available inactivated COVID-19 vaccine in accordance with national regulations before enrollment; 3. Volunteers who meet the requirements for participating in clinical studies based on medical history and physical examination; 4. I have the ability to understand the research procedure, voluntarily sign the informed consent after informed consent, and comply with the requirements of the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1.Previous vaccination with other COVID-19 vaccines other than inactivated vaccines; 2. The novel coronavirus nucleic acid test is positive; 3. (Inquiries) History of SARS, MERS and SARS-COV-2 infection; 4. Failed to take effective contraceptive measures within 2 weeks before being selected; Women and men who test positive for pregnancy in fertile women, who are pregnant, breastfeeding, or who plan to become pregnant within 6 months after vaccination; 5. (Inquiries) Have a history of epilepsy, convulsions, psychiatric history and family history; 6. (inquiries) Have a history of severe allergies, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction); Or have any previous history of severe adverse reactions to vaccines or drugs, such as allergy, urticaria, eczema, dyspnea, angioneurotic edema, etc.; 7. A history of hospital-diagnosed thrombocytopenia or other clotting disorders; 8. Hospital-diagnosed patients with known impairment or low immunological function, such as thyroid disease or history of thyroidectomy, absence of the spleen, functional absence of the spleen, and any other conditions resulting in absence of the spleen or splenectomy; 9. (Inquiries) Patients who have received whole blood, plasma and immunoglobulin treatment within 3 months; 10. Severe respiratory disease, liver or kidney disease, acute infection or active phase of chronic disease, complications of diabetes, malignant tumor, severe skin disease, HIV positive; Being treated with anti-TB drugs; 11. Patients with severe cardiovascular diseases (cardiopulmonary failure, medically uncontrollable hypertension (physical examination systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg). Chinese Guidelines for Hypertension Prevention and Treatment (3rd Edition), Revised 2021); 12. Patients with abnormal blood routine, blood biochemistry, coagulation function, urine routine, thyroid function and myocarditis who have clinical significance and cannot be enrolled by the comprehensive judgment of the researchers; 13. (Inquiries) Received subunit or inactivated vaccine within 14 days, or received live attenuated vaccine, nucleic acid vaccine, etc., within 1 month, or planned to receive any other vaccine (other than seasonal influenza vaccine or vaccine requiring emergency vaccination) during the study period; 14. Armpit temperature =37.3?; 15. Other researchers have identified contraindications associated with vaccination and inappropriate participation in the study, such as double upper arm tattoos.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Adverse events associated with the experimental vaccine;Laboratory related examination for adverse events;Geometric mean titer (GMT), Geometric mean Growth Multiple (GMI), seroprevalence of anti-Novel Coronavirus antibody;SAE;AESI; | — |
Countries
China
Contacts
Public ContactHuan Zhou?Qiang Wu
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed