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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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
• Другое 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

Первичные конечные точки

• The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in mucosal sample as calculated by Illumina NGS platform. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the enrollment to the end of the visit on the 28th ± 3rd day]

Критерии участия

Критерии включения

• volunteers aged 18 years and above at the time of screening;
• informed consent obtained from volunteers and volunteers/witnesses able to sign the informed consent form;
• an interval of ≥3 months from the last COVID-19 or influenza vaccination;
• 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.

Критерии исключения

• 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;
• Absence of spleen or functional absence of spleen;
• 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;
• Received blood products within the past 3 months;
• has received other vaccines or investigational drugs within the past 1 month;
• is receiving anti-tuberculosis treatment;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Zhongnan Hospital of Wuhan University — Ухань
• Zhongnan Hospital of Wuhan University — Ухань

Публикации

• 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. PMID 34174187
• 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; PMID 33171100
• 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. PMID 33789928

Идентификаторы

NCT: NCT06667063 · AMMS85-2401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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