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

NCT ID: NCT06667063

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2025-06-30

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.

Conditions

COVID-19; Influenza

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1:COVID-19 infected persons

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. COVID-19 antigen-positive and within 48 hours of onset of symptoms of infection;

Nasal swab/Nasopharyngeal swab/Blood sample collection

Intervention Type: OTHER

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

Cohort 2:Influenza virus infected persons

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. influenza virus antigen-positive and within 48 hours of onset of symptoms of infection;

Nasal swab/Nasopharyngeal swab/Blood draw

Intervention Type: OTHER

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

Cohort 3:Healthy Volunteers

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. COVID-19 and influenza virus antigen-negative, no febrile symptoms, and no symptoms of viral or bacterial respiratory infections.

Nasal swab/Nasopharyngeal swab/Blood draw

Intervention Type: OTHER

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

Interventions

Nasal swab/Nasopharyngeal swab/Blood sample collection

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

Intervention Type: OTHER

Nasal swab/Nasopharyngeal swab/Blood draw

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

Intervention Type: OTHER

Nasal swab/Nasopharyngeal swab/Blood draw

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

OTHER

Sponsor Role: collaborator

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianying Huang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianying Huang

Role: CONTACT

znyylcsy@126.com

02167811702

Jian Xia

Role: CONTACT

jianxia@whu.edu.cn

02167812521

Facility Contacts

Jianying Huang

Role: primary

znyylcsy@126.com

02167811702

Jianyuan Wu

Role: backup

02167812668

Jian Xia

Role: primary

jianxia@whu.edu.cn

02167812521

Jianyuan Wu

Role: backup

02167812668

References

Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.

Reference Type: BACKGROUND

PMID: 34174187 (View on PubMed)

Su Y, Chen D, Yuan D, Lausted C, Choi J, Dai CL, Voillet V, Duvvuri VR, Scherler K, Troisch P, Baloni P, Qin G, Smith B, Kornilov SA, Rostomily C, Xu A, Li J, Dong S, Rothchild A, Zhou J, Murray K, Edmark R, Hong S, Heath JE, Earls J, Zhang R, Xie J, Li S, Roper R, Jones L, Zhou Y, Rowen L, Liu R, Mackay S, O'Mahony DS, Dale CR, Wallick JA, Algren HA, Zager MA; ISB-Swedish COVID19 Biobanking Unit; Wei W, Price ND, Huang S, Subramanian N, Wang K, Magis AT, Hadlock JJ, Hood L, Aderem A, Bluestone JA, Lanier LL, Greenberg PD, Gottardo R, Davis MM, Goldman JD, Heath JR. Multi-Omics Resolves a Sharp Disease-State Shift between Mild and Moderate COVID-19. Cell. 2020 Dec 10;183(6):1479-1495.e20. doi: 10.1016/j.cell.2020.10.037. Epub 2020 Oct 28.

Reference Type: BACKGROUND

PMID: 33171100 (View on PubMed)

Clementi N, Ghosh S, De Santis M, Castelli M, Criscuolo E, Zanoni I, Clementi M, Mancini N. Viral Respiratory Pathogens and Lung Injury. Clin Microbiol Rev. 2021 Mar 31;34(3):e00103-20. doi: 10.1128/CMR.00103-20. Print 2021 Jun 16.

Reference Type: BACKGROUND

PMID: 33789928 (View on PubMed)

Other Identifiers

AMMS85-2401

Identifier Type: -

Identifier Source: org_study_id