Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
1:Middle-dose vaccine for subjects aged 18-55 years (0, 28 day regimen)
2:Middle-dose vaccine for subjects aged > 55 years (0, 28 day regimen)
3:Middle-dose vaccine for subjects aged 18 to 55 years (0, 28 day regimen)
4:High-dose vaccine for subjects aged > 55 years (0, 28 day regimen)
5:High-dose vaccine for subjects aged 18-55 years (0, 14, 28 day regimen)
6:High-dose vaccine for subjects aged >55 years (0, 14, 28 day regimen)
7:Placebo(0.5mL)for subjects aged 18-55 years (0, 28 day regimen)
8:Placebo(0.5mL) for subjects aged > 55 years (0, 28 day regimen)
9:Placebo (1ml) for subjects aged 18-55 years (0, 14, 28 day regimen)
10:Placebo (1ml) for subjects aged > 55 years (0, 14, 28 day regimen)
11:Placebo (1ml) for subjects aged 18-55 years (0, 28 day regimen)
12:Placebo (1ml) for subjects aged > 55 years (0, 28 day regimen)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged >=18 years old at the recruitment; 2. The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures; 3. They must be able to understand and follow trial-related instructions. They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial; 4. Negative in HIV antibody test; 5. Axillary temperature <=37.0 degrees C; 6. Negative finding in nucleic acid screening of SARS-CoV-2; 7. Negative in antibodies (IgG and IgM) test of SARS-CoV-2; 8. Negative finding in chest CT examine for COVID-19; 9. Body mass index (BMI) 18.5 to 30; 10. There were no significant abnormalities in blood routine, blood biochemistry, coagulation function and urine routine, or no clinical significance was determined by doctors (including white blood cell count, lymphocyte count, neutrophil count, platelet, hemoglobin, glutamic pyruvic transaminase ALT, glutamic oxaloacetic transaminase AST, total bilirubin, fasting blood glucose, creatinine, prothrombin time, partially activated prothrombin time, urine protein, urine red blood cells); 11. Healthy subjects who have been examined by medical history, physical examination and clinical examination are in accordance with the immunization of this vaccine.
Exclusion criteria
Exclusion criteria: Exclusion criteria of prime dose: 1. Subjects with a medical or family history of convulsions, epilepsy, encephalopathy, and psychosis; 2. Allergic to any ingredient in the study vaccine, or used to have a serious vaccine allergic reaction; 3. Women who are positive for urine pregnancy test. Women who are pregnant or breastfeeding or planning to be pregnant within 6 months; 4. Have acute febrile diseases or infectious diseases; 5. With history of SARS, SARS-CoV-2 or MERS infection; 6. People with serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and can not control using drugs; 7. Patients with severe chronic diseases or progressive conditions can not be smoothly controlled, such as asthma, diabetes, and thyroid diseases; 8. Have congenital or acquired angioedema/neuroedema; 9. Had urticaria 1 year before receiving the study vaccine; 10. Asplenium or functional aspleen; 11. Have thrombocytopenia or other coagulation disorders (may cause contraindications to intramuscular injection); 12. Have acupuncture syncope reaction; 13. Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis); 14. Received blood products within 4 months before receiving the study vaccine; 15. Received other study drugs within 1 month before receiving the study vaccine; 16. Received a live attenuated vaccine within 1 month before receiving the study vaccine; 17. Received a subunit or inactivated vaccine within 14 days before receiving the study vaccine; 18. Are receiving anti-tuberculosis treatment; 19. According to the judgment of the researchers, due to a variety of medical, psychological, social or other conditions, it is contrary to the trial scheme, or affects the subjects to sign informed consent; 20. It is contrary to the trial protocol, or affects the subjects to sign informed consent due to various medical, psychological, social or other conditions, according to the investigators judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo; | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (AE) within 7 days after each dose;Occurrence of AE up to Day 28 after prime and boost vaccination.;The proportion of SAEs up to Day 28 after prime and boost vaccination;The proportion of SAEs up to Month 12;The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.;GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.;Four-fold increase (seroconversion) in anti-RBD specific antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.;GMFI of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.;GMT of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.;Four-fold increase (seroconversion) in SARS-CoV-2 neutralizing antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.;GMFI of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination.;Seroconversion rates of IFN-? stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jiangsu Provincial Center for Disease Prevention and Control
Outcome results
None listed