COVID-19
Conditions
Interventions
1:Pilot batch
2:Commercial batch
Sponsors
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1.Subjects aged from 18-59 years. 2.Signed informed consent forms of the subjects have been obtained. 3.Able and willing to comply with the requirements of the clinical trial protocol and able to complete approximately 8 months of study follow-up. 4.Axillary temperature < 37.3?. 5.Subjects who fulfill all the required conditions for receiving the candidate vaccine as established by medical history and physical examination and determined by investigators.
Exclusion criteria
Exclusion criteria: Positive SARS-CoV-2 antibodies (IgG or IgM) screening results. Positive SARS-CoV-2 Antigen screening results. History of COVID-19 vaccination. Previously diagnosed with COVID-19 infection. History of HIV infection. History or family history of convulsion, epilepsy, encephalopathy and psychosis. Allergy to any component of the candidate vaccine, severe allergy to vaccine in the past, and history of allergy. Women with positive urine pregnancy test results, pregnant, lactating women, or women who have a pregnancy plan during the study. Patients with acute febrile diseases and infectious diseases. Patients with a history of SARS. Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by drugs, etc. Serious chronic diseases or progressive stage of a disease that cannot be steadily controlled, such as asthma, diabetes mellitus, thyroid disease, etc. Congenital or acquired angioedema/angioneurotic edema. Urticaria 1 year before receiving the candidate vaccine. Asplenia or functional asplenia. Thrombocytopenia or other coagulation disorders (which may contraindicate intramuscular injection). Fear of needles. Any immunosuppressant, antiallergic therapy, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months. Blood products within 4 months prior to receiving the candidate vaccine. Any other investigational medicine(s) within 1 month prior to the candidate vaccine. Any live attenuated vaccine within 1 month prior to the candidate vaccine. Any subunit vaccine or inactivated vaccine within 14 days prior to the candidate vaccine. Receiving antituberculosis treatment. Medical, psychological, social or other factors, which in the discretion of the investigators fail to meet the requirements in the trial protocol or affect the subjects to sign the ICFs. Exclusion criteria for the second/third dose: In this trial, the second/third vaccination may be stopped in some cases. They include systemic allergic reaction, severe hypersensitivity, or intolerable Grade 3 or above ARs after the previous dose of vaccine. If these reactions occur, the subjects should not continue to receive the second/third vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of ARs within 7 days after each vaccination;The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third dose vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of ARs within 21 days after the first dose and the second dose, and within 30 days after the third dose vaccination;The incidence of AEs within 21 days after the first dose and the second dose, and within 30 days after the third dose vaccination;The incidence of SAEs from the first dose through 6 months after the third dose vaccination;The GMI of the anti-SARS-COV-2 specific neutralizing antibody (euvirus) of the subjects on day 30 after the third dose vaccination;The GMT, SCR and GMI of anti-SARS-COV-2 S-RBD IgG antibody of the subjects on day 30 after the third dose vaccination; | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Outcome results
None listed