Prevention of novel coronavirus disease caused by SARS-CoV-2 coronavirus infection (COVID-19)
Conditions
Interventions
Group A :18-59 years old: one dose of 0.3 ml (30 µg) mRNA vaccine was given intramuscular injection
Group B:18 to 59 years old: intramuscular injection to receive 1 dose of 0.5 ml inactivated novel coronavirus vaccine (Vero cells) (ICV)
Group C:Over 60 years old: one dose of 0.3 ml (30 µg) mRNA vaccine was given intramuscular injection
Group D:Over 60 years old: intramuscular injection vaccination with 1 dose of 0.5 ml ICV
Group E:Over 60 years old: one dose of 0.3 ml (30 µg) mRNA vaccine was given intramuscular injection
Sponsors
Yixing People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 and over; 2. Able and willing to comply with the requirements of the clinical trial protocol, and able to sign the informed consent; 3. Willing to discuss medical history with researchers or doctors, and allow access to all medical records related to this trial; 4. The subject has completed 3 doses of inactivated vaccine vaccination, and the interval from the last vaccination is at least 6 months; 5. Possess a 48-hour nucleic acid test negative certificate at the time of screening.
Exclusion criteria
Exclusion criteria: 1. According to the investigator's judgment, the subject is not suitable to participate in the research; 2. Middle East Respiratory Syndrome (MERS), SARS or other coronavirus infection or disease history or related immunization history; 3. Have a history of severe vaccine or drug allergy or hypersensitivity in the past, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, hemorrhagic nerve edema, etc., or a history of serious adverse reactions related to vaccines and/or have no reaction to the research vaccines History of severe allergic reactions (such as anaphylaxis) to any component of the drug; 4. Immunocompromised persons with known or suspected immunodeficiency (such as HIV infection) confirmed by medical history and/or physical examination, unable to control autoimmune diseases, etc.; 5. Bleeding constitution or condition related to prolonged bleeding, the investigator believes that intramuscular injection is contraindicated; 6. Positive urine pregnancy test or breastfeeding women, volunteers or their partners have pregnancy plans within 6 months; 7. Severe hypertension that cannot be controlled by drugs (on-site measurement: systolic blood pressure >= 160 mmHg, diastolic blood pressure >= 100 mmHg); 8. Suffering from severe chronic disease or the disease is in a progressive stage and cannot be controlled smoothly, such as diabetes, hyperlipidemia, thyroid disease (thyroid nodule), etc.; 9. Suffering from severe myocarditis, pericarditis and other heart diseases in the past; 10. Those who plan to receive other vaccines within 28 days before and after receiving the experimental vaccine; 11. Those who received immunosuppressive therapy, including cytotoxic drugs or systemic corticosteroids, such as the treatment of cancer or autoimmune diseases, or planned to receive treatment throughout the study period. If systemic corticosteroids are used for a short period of time ( 37.0 ?, or use of non-prescription drugs such as antipyretic and analgesics (such as acetaminophen, ibuprofen, naproxen, etc.) within 12 hours before the vaccination of the experimental vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of anti-BA.5Omicron variant true virus neutralizing antibody level (GMT) and positive conversion rate in group A subjects 28 days after vaccination.;Evaluation of the incidence of adverse reactions (AR) in all subjects within 28 days after vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the incidence of adverse reactions/events in all subjects within 14 days of vaccination;Evaluation of the incidence of adverse events in all subjects within 28 days of vaccination;Evaluation of the incidence of SAE and AESI in all subjects at 6 months after vaccination;Evaluation of anti-BA.5Omicron variant true virus neutralizing antibody level (GMT) and positive conversion rate (before vaccination) in group A subjects before and 14 days after vaccination;Evaluation of anti-BA.5Omicron variant true virus neutralization and GMI in group A subjects at 14 and 28 days post-vaccination;Evaluation of anti-BA.5Omicron variant true virus neutralizing antibody levels (GMT), positive turnover rate, GMI at day 7, 3 months and 6 months after immunization in subjects 17 to 48 in each stratum of group A;Outcome: Evaluation of anti-BA.5Omicron variant S-RBD IgG antibody levels (GMC), positive conversion rate, and GMI (before vaccination) in group A subjects 14 and 28 days before and after vaccination;Evaluation of anti-BA.5Omicron variant S-RBD IgG antibody levels (GMC), positive conversion rate, and GMI at day 7, 3 months, and 6 months after vaccination in subjects 17 to 48 in each stratum of group A;Evaluation of serum anti-BA.5Omicron variant true virus neutralizing antibody >= 1:16 ratio at each time point in group A subjects;Evaluation of response levels and positivity of IL-2, IL-5, IL-13, and IFN-? produced by stimulation of the Omicron variant S protein RBD overlapping peptide library in the first 16 subjects in each stratum of group A before and on days 7, 14, and 28 after immunization measured by ELispot;Evaluation of antibody levels to other VOCs (Alpha, Beta, Gamma, Detla, BA4. and BA.5, etc.) on day 28 post-vaccination for subjects 17 to 48 in each stratum of group A; | — |
Countries
China
Contacts
Public ContactJundong Wu
Yixing People's Hospital
Outcome results
None listed