Clinical Study on the Immune Response Characteristics of Novel Coronavirus and Influenza Virus Infection

Recruiting

• Conditions: COVID-19; Influenza

• Registration Number: NCT06667063
• Lead Sponsor: Zhongnan Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2024-09-19
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Posted: 2024-10-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. volunteers aged 18 years and above at the time of screening;
2. informed consent obtained from volunteers and volunteers/witnesses able to sign the informed consent form;
3. an interval of ≥3 months from the last COVID-19 or influenza vaccination;
4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs; 5.1 cohort 1：novel coronavirus virus antigen-positive and within 48 hours of onset of symptoms of infection; 5.2 cohort 2：influenza virus antigen-positive and within 48 hours of onset of symptoms of infection; 5.3 cohort 3：novel coronavirus and influenza virus antigen-negative, no febrile symptoms, and no symptoms of viral or bacterial respiratory infections.

Exclusion Criteria

1. known or suspected concomitant more serious and medically unstable disease in the judgment of the investigator, including: respiratory disease, tuberculosis, acute infections or active chronic disease, hepatic or renal disease, cardiovascular disease (cardiorespiratory failure), hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), malignant tumors, infectious or allergic skin diseases, and the presence of HIV infection;
2. Absence of spleen or functional absence of spleen;
3. immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis) within the past 6 months;
4. Received blood products within the past 3 months;
5. has received other vaccines or investigational drugs within the past 1 month;
6. is receiving anti-tuberculosis treatment;
7. In the judgment of the investigator, due to a variety of medical, psychological, social, or other conditions that are contrary to the trial protocol or that affect the signing of informed consent by the volunteer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in mucosal sample as calculated by Illumina NGS platform.	From the enrollment to the end of the visit on the 28th ± 3rd day	Measuring method: Single-cell RNA sequencing. Metric/method of measurement: cell frequency
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	From the enrollment to the end of the visit on the 28th ± 3rd day	Measuring method: Real-Time RT-PCR Metric/method of measurement: Ct value
The SARS-CoV-2, Influenza A and Influenza B-specific IgG titer in serum sample assessed by ELISA.	From the enrollment to the end of the visit on the 28th ± 3rd day	Measuring method: ELISA Metric/method of measurement: antibody titer
The level of IL-1β, IL-6, IFN-gamma, MCP-1, CXCL9, CXCL10, MCP-1 and TNF-alpha in serum sample assessed by Luminex.	From the enrollment to the end of the visit on the 28th ± 3rd day	Measuring method: Luminex Metric/method of measurement: concentration
The transcriptome profiles of peripheral blood mononuclear cell assessed by RNA-sequencing Measuring method: RNA-sequencing	From the enrollment to the end of the visit on the 28th ± 3rd day	Metric/method of measurement: gene count
The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in blood sample as assessed by the flow cytometer	From the enrollment to the end of the visit on the 28th ± 3rd day	Measuring method: flow cytometer Metric/method of measurement: cell frequency

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China