Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
1 (inactivated vaccine group):subjects were injected with 1 dose of inactivated COVID-19 vaccine (intramuscular injection) at the baseline (day 0)
2 (recombinant protein vaccine group): the subjects were injected with 1 dose of recombinant protein vaccine (intramuscular injection) at the baseline (day 0)
Control group:no intervention
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult subjects (18 years old), no gender limitation; 2.Subjects in good health or stable clinical situation; 3.Subjects who completed two doses of inactivated COVID-19 vaccine 4-8 months ago; 4.Female subjects of childbearing age are not breast-feeding or pregnant (negative blood pregnancy test), and have no family planning in the first 3 months after enrollment. Take effective contraceptive measures within 2 weeks before enrollment; 5.Participant is willing and able to adhere to the procedures specified in this protocol; 6.Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
Exclusion criteria
Exclusion criteria: The participant may not enter the trial if ANY of the following apply: 1.SARS-CoV-2 infection confirmed by RT-qPCR detection; 2.Clinical manifestations including fever, dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, dyspnea, etc.; 3.Body temperature >37.0 degree C before vaccination; 4.Urine pregnancy test positive; 5.Severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioedema or abdominal pain) or allergic to the known ingredients of the inactivated SARS-CoV-2 vaccine; 6.History or family history of convulsions, epilepsy, encephalopathy or mental illness; 7.Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. 8.Suffer from severe liver and kidney disease, uncontrollable hypertension (systolic blood pressure>=140 mmHg, diastolic blood pressure>=90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attacks of chronic diseases; 9.Diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 10.Are receiving anti-tuberculosis treatment; 11.Known or suspected diseases include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases and malignant tumors; 12.History of coagulation dysfunction (such as coagulation factor deficiency, coagulation disease); 13.Receipt of immunotherapy or inhibitor treatment within 3 months (continuous oral or infusion for more than 14 days); 14.Receipt of any live attenuated vaccine within 1 month before this vaccination, and other vaccines within 14 days before this vaccination; 15.Receipt of other study drugs within 6 months before vaccination; 16.The investigator judged that it is not suitable for other situations in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of effective immune reactivation on the 14th day of enrollment (Geometric mean titers (GMTs) of neutralizing antibodies produced in response to SARS-CoV-2 live virus increased 4 times or more from baseline, or changed from negative to positive from baseline); | — |
Countries
China
Contacts
Public ContactRonghua Jin
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed