COVID-19
Conditions
Interventions
Group 1 :Intramuscular Ad5-nCoV
Group 2:Aerosol Ad5-nCoV
Group 3:Intramuscular ZF2001
Group 4:Intramuscular inactivated vaccine
Group 5:Aerosol Ad5-nCoV
Sponsors
Health Service Department of the Guard Bureau of the General Office of the Central Committee of the Communist Party of China
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18-59 years, who have been vaccinated with the inactive COVID-19 vaccine, Ad5-Vectored vaccine or the recombinant protein subunit vaccine at least 6 months ago; 2. The subject can provide with informed consent and sign informed consent form (ICF); 3. The subjects are able to and willing to comply with the requirements of this trial and could complete the 6-month follow-up of the study; 4. Individuals who are in good health condition and meet the requirements of vaccination.
Exclusion criteria
Exclusion criteria: 1. History or family history of convulsions, epilepsy, encephalopathy or psychosis; 2. Is allergic to any component of the vaccine, or has a history of allergy or severe reaction to the vaccine; 3. Women who have a positive urine pregnancy test, are pregnant or breastfeeding, or have plans to become pregnant within six months; 4. Suffering from acute febrile and infectious diseases; 5. Have a serious chronic disease or condition that cannot be controlled; 6. Congenital or acquired angioedema/neuroedema; 7. Immunosuppressive therapy, antiallergy therapy, cytotoxic therapy, or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and acute corticosteroid therapy without dermatitis) within the past 6 months; 8. Received blood products within 4 months prior to receiving the study vaccine; 9. Receiving anti-tuberculosis treatment; 10. Inability to comply with the protocol or to understand the informed consent in the investigator's judgment due to various medical, psychological, social or other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibodies against SARS-CoV-2 virus on day 14 after the booster dose;Binding antibodies against SARS-CoV-2 Spike on day 14 after the booster dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutralizing antibodies against SARS-CoV-2 virus on day 28, 3 month, 6 month after the booster dose.;Binding antibodies against SARS-CoV-2 spike on day 7, day 28, 3 month, 6 month after the booster dose;Specific T cell responses on day 14 and 28 after the booster vaccination;Specific memory B cell responses on day 14 and 28 after the booster vaccination; | — |
Countries
China
Contacts
Public ContactSun Yufa
Health Service Department of the Guard Bureau of the General Office of the Central Committee of the Communist Party of China
Outcome results
None listed