Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
1:18-59 years group, 20 ug vaccine injection on day 0, day 21
2:60-85 years groupm 20 ug vaccine injection on day 0, day 21
3:18-59 years group, 40 ug vaccine injection on day 0, day 21
4:60-85 years group, 40 ug vaccine injection on day 0, day 21
5:18-59 years group, 20 ug vaccine injection on day 0, day 14, day 28
6:60-85 years group, 20 ug vaccine injection on day 0, day 14, day 28
7:18-59 years group, 40 ug vaccine injection on day 0, day 14, day 28
8:60-85 years group, 40 ug vaccine injection on day 0, day 14, day 28
9:18-59 years, placebo 0.5 ml injection on day 0, day 21
10:60-85 years, placebo 0.5 ml injection on day 0, day 21
11:18-59 years group, placebo 1.0 ml injection on day 0, day 21
12:60-85 years group, placebo 1.0 ml injection on day 0, day 21
13:18-59 years, placebo 0.5 ml injection on day 0, day 14, day 28
14:60-85 years group, placebo 0.5 ml injection on day 0, day 14, day 28
15:18-59 years group, placebo 1.0 ml injection on day 0, day 14, day 28
16:60-85 years, placebo 1.0 ml injection on day 0, day 14, day 28
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above; 2. Able to understand the content of informed consent and willing to sign the informed consent; 3. Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months); 4. Axillary temperature <= 37.0 degree C; 5. General good health as established by medical history and physical examination.
Exclusion criteria
Exclusion criteria: 1. Positive serum IgM and IgG to the SARS-CoV-2; 2. History of HIV infection 3. Family history of seizure, epilepsy, brain or mental disease. 4. Participant that has an allergic history to any ingredient of vaccines; 5. oman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months; 6. Any acute fever disease or infections; 7. Have a medical history of SARS; 8. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled; 9. Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled; 10. Hereditary angioneurotic edema or acquired angioneurotic edema; 11. Urticaria in last one year; 12. Asplenia or functional asplenia; 13. Platelet disorder or other bleeding disorder may cause injection contraindication; 14. Faint at the sight of blood or needles; 15. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months; 16. Prior administration of blood products in last 4 months; 17. Prior administration of other research medicines in last 1 month; 18. Prior administration of attenuated vaccine in last 1 month; 19. Prior administration of subunit vaccine or inactivated vaccine in last 14 days; 20. Being treated for tuberculosis; 21. Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMT of anti-RBD specific antibody at Month 1 after boost vaccination.;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 AE up to Month 1 after prime and boost vaccination.;The proportion of SAEs up to Month 1 after prime and boost vaccination;The proportion of SAEs in the 6th month after prime and boost vaccination;GMT of SARS-CoV-2 neutralizing antibody at Month 1 after boost vaccination.;GMT of anti-RBD specific antibody at Day 14 after boost vaccination.;seroconversion in anti-RBD specific antibody titers, at Day 14, Day 30 after boost vaccination.;GMI of anti-RBD specific antibody at Day 14, Day 30 after boost vaccination.;GMT of SARS-CoV-2 neutralizing antibody at Day 14 after boost vaccination.;seroconversion in SARS-CoV-2 neutralizing antibody titers, at Day 14, Day 30 after boost vaccination.;GMFI of SARS-CoV-2 neutralizing antibody at Day 14, Day 30 after prime and boost vaccination.; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jiangsu Provincial Center for Disease Prevention and Control
Outcome results
None listed