Clinical trial Recruiting at 1 site Observational Ages 20 to 75

Investigating respiratory viruses and immunity in healthy individuals in Shanghai

Official title: Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai

Run by Ruijin Hospital · NCT06641856 · Data updated 2026-11-12

This study is trying to understand the variety of respiratory viruses in healthy young adults in Shanghai and how factors like age and gender affect their immune responses.

Quick facts

Study typeObservational
Ages20 Years to 75 Years
SexAll
Enrollment300 (estimated)
SponsorRuijin Hospital
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedSeptember 2, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 29, 2024
Trial IDNCT06641856 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are healthy young adults aged 20-35, of Han ethnicity, with a normal BMI and no significant health issues.

Probably not a fit

Patients outside the specified age range, those with health conditions, or individuals who are pregnant or lactating may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study explores the diversity of the respiratory virome in healthy individuals aged 20-35 in Shanghai, focusing on how demographic factors like age and gender influence virome composition. It aims to collect samples from the upper and lower respiratory tracts and analyze them using multi-omics approaches to understand the immune response mechanisms related to virome diversity. The study will also establish a respiratory virome database and identify previously unknown viral sequences that may interact with the immune system.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of respiratory virome diversity and its implications for immune health in healthy individuals.

How similar studies have gone: While research on respiratory viromes is emerging, this specific focus on healthy individuals in Shanghai is relatively novel and has not been extensively tested in similar studies.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.