SARS-CoV-2
Conditions
Interventions
intranasal vaccination (low dose):intranasal vaccination with NB2155, 2 doses with an interval of 28 days, 2E10vp/dose
intranasal vaccination(high dose)):intranasal vaccination with NB2155, 2 doses with an interval of 28 days, 4E10vp/dose
Sponsors
The First Affiliate Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Age in 18~69 years old, and can provide legal identity certification 2. agrees to participate in the research and signs an informed consent form voluntarily 3. can understand the research procedures and participate in all planned follow-up visits 4. population with infection risk 5. have received 2 or 3 doses of COVID-19 inactivated vaccine and the last dose has been inoculated for more than 3 months. 6. Women who are not pregnant or lactating. 7. Body temperature <37.3°C
Exclusion criteria
Exclusion criteria: 1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological or neurological diseases. 2. History of chronic respiratory diseases, including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (<= 14 days before screening) or ongoing respiratory infection. 3. history of thrombosis (such as deep vein thrombosis, pulmonary embolism, etc.), any coagulation disorder disease, or immediate family members have a history of thrombosis. 4. History of any neurological disorder or seizures, including Guillain-Barré syndrome, with the exception of febrile seizures in childhood. 5. history of malignant disease in the past 5 years. 6. history of clinically relevant immunosuppression, but not limited to immunodeficiency diseases, such as common variable hypoimmunoglobulinemia. 7. Pregnant (or possibly pregnant) and lactating women. 8. intranasal steroids within 10 days before study enrollment. 9. history of chronic rhinitis or existing nasal septum defects, nasal polyps or other serious abnormalities. 10. Prior surgery with nasal cautery or septal defect. 11. any conditions that may interfere with the evaluation according to the PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Efficacy;Immunogenicity; | — |
Countries
China
Contacts
Public ContactBaoqing SUN
The First Affiliate Hospital, Guangzhou Medical University
Outcome results
None listed