Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged above 18 years; 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 follow-up period of 6 months. 4. Negative in HIV diagnostic test; 5. Axillary temperature <=37.0 degree C; 6. Negative in serum antibodies (IgG and IgM) screening of COVID-19. 7. The BMI index 18.5-30.0; 8. General good health as established by medical history and physical examination.
Exclusion criteria
Exclusion criteria: 1. Family history of seizure, epilepsy, brain or mental disease; 2. Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past; 3. Woman who is pregnant, breast-feeding or positive in ß-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months; 4. Any acute fever disease or infections; 5. History of SARS; 6. Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease; 7. Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.; 8. Hereditary angioneurotic edema or acquired angioneurotic edema; 9. Urticaria in last one year; 10. No spleen or functional spleen; 11. Platelet disorder or other bleeding disorder may cause injection contraindication; 12. Faint at the sight of needles; 13. Prior administration of immunodepressant or corticosteroids,antianaphylaxis treatment, cytotoxic treatment in last 6 months; 14. Prior administration of blood products in last 4 months; 15. Prior administration of other research medicines in last 1 month; 16. Prior administration of attenuated vaccine in last 1 month; 17. Prior administration of inactivated vaccine in last 14 days; 18. Current anti-tuberculosis prophylaxis or therapy; 19. According to the judgement of investigator,various medical, psychological,social or other conditions, those could affect the subjects to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions 0-14 days post vaccination;Anti-S antibody IgG titer on day 28 post vaccination;Anti-SARS-CoV-2 neutralizing antibody titer on day 28 post vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions 0- 28 days post vaccination;SAE within 6 months post vaccination;Anti-S antibody IgG titer on day 14, month 6 post vaccination;Anti-SARS-CoV-2 neutralizing antibody titer on day 14,month 6 post vaccination;Anti-Ad5 neutralizing antibody on day 28 and 6 month post vaccination; | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed