Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai
Ruijin Hospital
300 participants
Sep 2, 2024
OBSERVATIONAL
Conditions
Summary
This study investigates the diversity of the respiratory virome in healthy individuals in Shanghai and its interaction with the host's baseline immune response. The respiratory virome plays a critical role in various diseases, but research on the respiratory virome in healthy individuals in China is limited. This prospective study will analyze the upper and lower respiratory virome and examine the effects of demographic factors such as age, gender, and geographic background. Additionally, a respiratory virome database will be established, and multi-omics approaches will be used to study immune response mechanisms in relation to virome diversity.
Eligibility
Inclusion Criteria12
- \. Young Healthy Volunteers
- Age between 20-35 years (inclusive), Han ethnicity, regardless of gender. Body Mass Index (BMI) between 19-26 kg/m² (inclusive), with a minimum weight of 50 kg for males and 45 kg for females.
- The participant must be in good overall health, as determined by medical history, physical examination, vital signs, and results from a health checkup within the past year (normal or clinically insignificant findings).
- Female participants must be non-pregnant and non-lactating.
- Able to tolerate bronchoscopy and willing to provide nasal and pharyngeal swabs, as well as upper and lower respiratory secretions and peripheral blood samples.
- Fully informed of the study's purpose, methods, and potential discomforts, with written informed consent provided, and willing to complete the study questionnaire.
- Good compliance and willingness to follow the study protocol and complete follow-up procedures.
- Age between 60-75 years (inclusive), Han ethnicity, regardless of gender. Body Mass Index (BMI) between 19-26 kg/m² (inclusive), with a minimum weight of 50 kg for males and 45 kg for females.
- The participant must have a healthy respiratory system, as determined by medical history, physical examination, vital signs, and results from a health checkup within the past year (normal or clinically insignificant findings).
- Able to tolerate bronchoscopy and willing to provide nasal and pharyngeal swabs, as well as upper and lower respiratory secretions and peripheral blood samples.
- Fully informed of the study's purpose, methods, and potential discomforts, with written informed consent provided, and able to independently complete the study questionnaire.
- Good compliance and willingness to follow the study protocol and complete follow-up procedures.
Exclusion Criteria20
- Non-permanent residents of Shanghai who have stayed in the city for more than 30 days; or permanent residents of Shanghai who have left the city within the past 30 days.
- History of significant illness or major surgery within the past 30 days, or anticipation of major surgery during the study period.
- Diagnosis of respiratory diseases (infectious or non-infectious) within the past 30 days, requiring medication (oral, inhaled, or nebulized).
- Presence of clinically significant diseases or factors, including but not limited to neurological, cardiovascular, hematologic, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal diseases, or other conditions deemed unsuitable by the investigator.
- Long-term use of medication.
- Positive test results for HIV antibodies (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV-Ab), or syphilis antibodies (TP-Ab).
- Participation in any drug or medical device clinical trial within the past 3 months.
- Vaccination within the past 30 days or planned vaccination during the study period.
- Any other condition deemed by the investigator to impact the participant's ability to provide informed consent, follow the protocol, or affect study outcomes or the participant's safety.
- \. Elderly Healthy Volunteers
- Non-permanent residents of Shanghai who have stayed in the city for more than 30 days; or permanent residents of Shanghai who have left the city within the past 30 days.
- History of significant illness or major surgery within the past 30 days, or anticipation of major surgery during the study period.
- Diagnosis of respiratory diseases (infectious or non-infectious) within the past 30 days, requiring medication (oral, inhaled, or nebulized).
- Presence of abnormal respiratory system function or other clinically significant diseases or conditions.
- History of malignant tumors (including hematologic malignancies or solid tumors).
- Long-term use of medication.
- Positive test results for HIV antibodies (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV-Ab), or syphilis antibodies (TP-Ab).
- Participation in any drug or medical device clinical trial within the past 3 months.
- Vaccination within the past 30 days or planned vaccination during the study period.
- Any other condition deemed by the investigator to impact the participant's ability to provide informed consent, follow the protocol, or affect study outcomes or the participant's safety.
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Interventions
All participants will provide nasal and pharyngeal swabs for virome analysis. A subset of 30 elderly volunteers will also provide peripheral blood samples and undergo bronchoscopy under general anesthesia to collect upper and lower respiratory tract samples.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06641856