This is an open-label, prospective observational study in people 18 years of age and older designed to track changes in the dynamics of the respiratory and peripheral blood immune response in people infected with influenza virus and new coronaviruses, and to resolve the characteristics of the virus-induced natural immune response.
The clinical trial enrolls 130 subjects aged 18 years and older with ≥3 months between their last COVID-19/influenza vaccination or respiratory virus infection. Mucosal and peripheral blood samples will be collected from COVID-19-infected and influenza-infected patients during the preinfection, infection, and recovery periods, and cytokines, immune cell typing, immune cell transcription, and specific antibody levels will be examined in these patients. Levels of cytokines, immune cell typing, immune cell gene transcription, specific antibodies, etc.
Study Type
OBSERVATIONAL
Enrollment
130
Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing
Visit 1/2/3:Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing
Visit 1/2/3:Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGThe frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in mucosal sample as calculated by Illumina NGS platform.
Measuring method: Single-cell RNA sequencing. Metric/method of measurement: cell frequency
Time frame: From the enrollment to the end of the visit on the 28th ± 3rd day
The Ct value of SARS-CoV-2 N gene, Influenza A HA gene and Influenza B PA gene in mucosal sample as assessed by Real-Time RT-PCR
Measuring method: Real-Time RT-PCR Metric/method of measurement: Ct value
Time frame: From the enrollment to the end of the visit on the 28th ± 3rd day
The SARS-CoV-2, Influenza A and Influenza B-specific IgG titer in serum sample assessed by ELISA.
Measuring method: ELISA Metric/method of measurement: antibody titer
Time frame: From the enrollment to the end of the visit on the 28th ± 3rd day
The level of IL-1β, IL-6, IFN-gamma, MCP-1, CXCL9, CXCL10, MCP-1 and TNF-alpha in serum sample assessed by Luminex.
Measuring method: Luminex Metric/method of measurement: concentration
Time frame: From the enrollment to the end of the visit on the 28th ± 3rd day
The transcriptome profiles of peripheral blood mononuclear cell assessed by RNA-sequencing Measuring method: RNA-sequencing
Metric/method of measurement: gene count
Time frame: From the enrollment to the end of the visit on the 28th ± 3rd day
The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in blood sample as assessed by the flow cytometer
Measuring method: flow cytometer Metric/method of measurement: cell frequency
Time frame: From the enrollment to the end of the visit on the 28th ± 3rd day
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