NCT06641856 Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai
| NCT ID | NCT06641856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Health Personnel |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-09-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
1\. Young Healthy Volunteers Inclusion Criteria: 1. 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. 2. 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). 3. Female participants must be non-pregnant and non-lactating. 4. Able to tolerate bronchoscopy and willing to provide nasal and pharyngeal swabs, as well as upper and lower respiratory secretions and peripheral blood samples. 5. Fully informed of the study's purpose, methods, and potential discomforts, with written informed consent provided, and willing to complete the study questionnaire. 6. Good compliance and willingness to follow the study protocol and complete follow-up procedures. Exclusion Criteria: 1. 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. 2. History of significant illness or major surgery within the past 30 days, or anticipation of major surgery during the study period. 3. Diagnosis of respiratory diseases (infectious or non-infectious) within the past 30 days, requiring medication (oral, inhaled, or nebulized). 4. 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. 5. Long-term use of medication. 6. Positive test results for HIV antibodies (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV-Ab), or syphilis antibodies (TP-Ab). 7. Participation in any drug or medical device clinical trial within the past 3 months. 8. Vaccination within the past 30 days or planned vaccination during the study period. 9. 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. 2\. Elderly Healthy Volunteers Inclusion Criteria: 1. 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. 2. 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). 3. Able to tolerate bronchoscopy and willing to provide nasal and pharyngeal swabs, as well as upper and lower respiratory secretions and peripheral blood samples. 4. Fully informed of the study's purpose, methods, and potential discomforts, with written informed consent provided, and able to independently complete the study questionnaire. 5. Good compliance and willingness to follow the study protocol and complete follow-up procedures. Exclusion Criteria: 1. 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. 2. History of significant illness or major surgery within the past 30 days, or anticipation of major surgery during the study period. 3. Diagnosis of respiratory diseases (infectious or non-infectious) within the past 30 days, requiring medication (oral, inhaled, or nebulized). 4. Presence of abnormal respiratory system function or other clinically significant diseases or conditions. 5. History of malignant tumors (including hematologic malignancies or solid tumors). 6. Long-term use of medication. 7. Positive test results for HIV antibodies (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV-Ab), or syphilis antibodies (TP-Ab). 8. Participation in any drug or medical device clinical trial within the past 3 months. 9. Vaccination within the past 30 days or planned vaccination during the study period. 10. 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.
Contact & Investigator
Jieming Qu, Ph. D
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT06641856 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 75 Years, studying Health Personnel. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06641856 currently recruiting?
Yes, NCT06641856 is actively recruiting participants. Contact the research team at yjy19960816@163.com for enrollment information.
Where is the NCT06641856 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06641856 clinical trial?
NCT06641856 is sponsored by Ruijin Hospital. The principal investigator is Jieming Qu, Ph. D at Ruijin Hospital. The trial plans to enroll 300 participants.