Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Inoculate the test vaccine on day 0 and 14
Control group:Placebo control vaccine was administered on day 0 and 14
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 91 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years old at the time of enrollment; 2.Be able to comply with the requirements of clinical study protocol and complete all trial procedures, and sign informed consent form; 3.Subjects who have not received any COVID-19 vaccine (marketed or investigational), those who have received at least one dose of other COVID-19 vaccines (marketed or investigational) with an interval of >= 6 months between the last dose and the date when the subjects sign the informed consent for this study; 4.Patients who are negative for HIV screening (depending on the relevant policy of the country where the trial is conduct, if qualification for HIV testing is required in the country, this information will be obtained mainly by inquiry while protecting the candidates privacy); 5.Fertile males and females of childbearing potential who are willing to take appropriate contraceptive measures from signing inform consent form to 3 months after the last dose, including abstinence or effective contraceptive measures (e.g., intrauterine or implantable contraceptive devices, oral contraception, combination of contraceptive diaphragm or condom with contraceptive gel); women of childbearing potential should be negative for pregnancy test on the day of vaccination; 6.Healthy people or people with a mild underlying disease that has remained stable without exacerbation (not requiring hospitalization or without major modification of the treatment regimen) within at least 3 months prior to inclusion in the study.
Exclusion criteria
Exclusion criteria: 1.Prior history of COVID-19, or SARS-CoV-2 RT-PCR-positive at screening; 2.Positive test of total SARS-CoV-2 specific antibody using colloidal gold reagent [Only applicable to subjects without vaccination history of COVID-19 vaccine (marketed or investigational)]; 3.Pregnant or lactating women; 4.Fever on the day of vaccination or within 3 days prior to vaccination (oral temperature >= 37.5 ?/ear temperature >= 37.5? /axillary temperature >= 37.3 ?); 5.Patients who had any acute disease in the past 5 days that requires systemic antibiotic or antiviral treatment (including but not limited to the use of anti-influenza virus drugs such as Tamiflu, Relenza, Symmetrel or Flumadine); 6.Patients who had low immune function caused by immunodeficiency diseases, diseases of important organs, cancer, and immune diseases (e.g. Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy caused by any condition, and other immune disease that may affect immune response at the investigators discretion); 7.Long-term use (defined as >= 14 days) of immunosuppressants or other immunomodulators (for glucocorticoids, e.g., >= 10 mg/day prednisone or equivalent dose; inhaled and topical steroids are allowed) within 6 months prior to the first vaccination; 8.History of hemorrhagic diseases (e.g., factor deficiency, thrombocytopenia or other coagulation disorders), or hemorrhagic tendency, or continuous requirement of anticoagulants; 9.Having received immunoglobulins and/or blood products within 3 months before receiving the investigational vaccine; 10.Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination; 11.Participation in a clinical trial of another product within 1 month prior to vaccination, or planning to participate in a clinical trial of another product during the study; 12.Having a history of severe allergic reactions or severe adverse reactions from previous immunizations, or allergy to any component of the investigational vaccine; 13.Patients deemed by the investigator as unsuitable for using nasal spray (those with severe rhinitis or nasal deformities, etc.); 14.Planning to relocate permanently from the current area prior to the completion of the study or to leave the current area for a long period (preventing compliance with the prescribed visit schedule) during the study visits; 15.Other conditions that the investigators consider unsuitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occurs for the first time at least 14 days (= 15 days) after the second vaccination.;All serious adverse events (SAEs), other medically attended AEs (MAAEs), and adverse events of special interest (AESIs) from the first dose to 12 months after the second dose in all subjects;All solicited adverse events within 7 days following the first and second vaccinations in all subjects;All unsolicited adverse events that occur during the interval between doses and within 30 days after the second vaccination in all subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occurs for the first time at least 14 days (= 15 days) after the second vaccination in subjects with or without COVID-19 vaccination history previously.;irologically confirmed (RT-PCR-positive) severe and above COVID-19 cases that occurs for the first time at least 14 days (= 15 days) after the second vaccination.; Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occur for the first time at least 14 days after the second vaccination (= 15 days) in subjects aged 18-59 and =60 years.;Virologically confirmed (RT-PCR-positive) death cases resulting from COVID-19 that occur at least 14 days after the second vaccination (= 15 days).;Virologically confirmed (RT-PCR-positive) symptomatic COVID-19 cases of any severity that occur for the first time at least 14 days after the second vaccination (= 15 days) in subjects with a clear chronic disease.; | — |
Countries
Vietnam
Contacts
Public ContactZhu Fengcai
Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Jiangsu Provincial)
Outcome results
None listed