diseases caused by novel coronavirus (SARS-CoV-2) infection (COVID-19)
Conditions
Interventions
Group 1:Nebulized inhalation device for oral inhalation of test vaccine 1
immunization dose: 0.1 ml/visit
Group 2:Nebulized inhalation device transoral inhalation test vaccine 2
Group 3:Nebulized inhalation device for transoral inhalation of control vaccine
Sponsors
Chongqing Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteers are 18 years of age or older at the time of screening. 2. Informed consent was obtained from the volunteers and the volunteers or witnesses were able to sign the informed consent form. 3. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the 6-month study follow-up. 4. Have completed 3 doses of novel inactivated coronavirus vaccine with an interval of >=3 months between the last dose and enrollment. 5. Provide proof of negative nucleic acid within 48h at the time of screening.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of medical treatment in the last five years for convulsions, epilepsy, encephalopathy and severe neurological diseases (e.g. transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.). 2. Those who are allergic to the active ingredient of the investigational vaccine, any of the inactive ingredients, substances used in the production process, or those who have developed allergy during previous vaccinations of the same type; those who have had severe allergic reactions to vaccines in the past (e.g. acute allergic reactions, angioneurotic edema, respiratory distress, etc.), a previous history of severe allergy to any vaccine, food, or drug, such as: urticaria, anaphylaxis, skin eczema Allergic dyspnea, angioneurotic edema, etc. or a history of asthma. 3. Subjects with serious adverse events related to vaccination after previous vaccination. 4. Women of childbearing age with a positive urine pregnancy test or lactating subjects, where the subject or her partner has plans to become pregnant within 6 months. 5. Subjects with infectious diseases or infections undergoing treatment. 6. Subjects with fever and axillary body temperature >37.0°C. 7. Known or suspected concurrent more serious illnesses in the judgment of the investigator, including: diabetes, thyroid disease, respiratory disease, tuberculosis, acute infection or active chronic disease, liver or kidney disease, cardiovascular disease (cardiopulmonary failure), medically uncontrollable hypertension (systolic blood pressure >= 160 mmHg, diastolic blood pressure >= 100 mmHg), malignancy, infectious or allergic skin disease, presence of HIV infection (test report available). 8. Subjects with no spleen or functional absence of spleen. 9. Subjects suffering from thrombocytopenia, bleeding disorders, or other coagulation disorders. 10. Subjects suffering from nasal or oral diseases such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, and throat redness. 11. Suffering from chronic obstructive pulmonary disease, pulmonary fibrosis and other lung function abnormalities. 12. Subjects who have had immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute uncomplicated dermatitis) within the past 6 months. 13. Subjects who have received blood products within 4 months prior to receiving the test vaccine. 14. The Subject has received another vaccine or study drug within 1 month prior to receiving the trial vaccine. 15. The subject is receiving anti-tuberculosis treatment. 16. The subject has a history of neocoronavirus infection/illness, a history of SARS. 17. In the judgment of the investigator, due to various medical, psychological, social conditions or other conditions that are contrary to the trial protocol or that affect the Subject's ability to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT) of anti-Omicron-specific neutralizing antibodies (true virus) on day 28 post-immunization, positive conversion rate (>= 4-fold increase compared to pre-immunization);Incidence of adverse reactions (AR) within 0 to 28 days after immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions 30 min after immunization;Incidence of adverse reactions/adverse events within 14 days after immunization;Incidence of adverse events within 28 days after exemption;Incidence of serious adverse events (SAE) within 6 months after vaccination;GMT, positive conversion rate (>=4 times higher than before) and GMI of antigen-specific neutralizing antibody (true virus) on day 28 after exemption;Anti-Omicron specific neutralizing antibody (true virus) GMI on day 28 after immunization;Positive conversion rate (>=4 times higher than before exemption), GMT and GMI of anti-Omicron and proto-strain specific neutralizing antibody (true virus) at 14 days, 3 months and 6 months after exemption;Positive conversion rate (>=4 times higher than before), GMC and GMI of anti-Omicron and S-RBD IgG at 14 days, 28 days, 3 months and 6 months after immunization;Stratification of anti-Omicron and proto-viral strain-specific neutralizing antibodies (true virus) and anti-Omicron and proto-viral strain S-RBD IgG based on pre-immune Ad5 levels;GMT, positive conversion rate, GMI for partial VOC/VOI cross-neutralization on day 28 after exemption; | — |
Countries
China
Contacts
Public ContactWang Qing
Outcome results
None listed