Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai

Recruiting

• Conditions: Health Personnel

• Registration Number: NCT06641856
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

The study aims to provide comprehensive baseline data on the respiratory virome in healthy individuals in Shanghai. The primary goal is to investigate virome diversity in the upper and lower respiratory tracts and assess how demographic factors influence virome composition. Furthermore, the study will identify previously unknown viral sequences and explore their potential role in the immune system's interaction with the virome. Multi-omics approaches, including transcriptomics and proteomics, will be utilized to evaluate immune-related biomarkers and gene expression related to respiratory virome diversity.

Study Timeline

• Study Start: 2024-09-02
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

10. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virome Composition and Diversity	From date of inclusion until the date of final quantification, assessed up to 6 months	Characterization of respiratory virome diversity in upper and lower respiratory tracts of healthy individuals, measured through viral sequencing of nasal, throat, and bronchoscopic samples.
Host Immune Response	From date of inclusion until the date of final quantification, assessed up to 6 months	Analysis of immune-related biomarkers and gene expression in blood samples, focusing on the interaction between respiratory virome diversity and the host immune response.

Secondary Outcome Measures

Name	Time	Method
Virome and Demographic Correlation	From date of inclusion until the date of final quantification, assessed up to 6 months	Analysis of the correlation between virome composition and demographic factors such as age, gender, and geographic location.
Discovery of Unknown Viruses	From date of inclusion until the date of final quantification, assessed up to 6 months	Identification of novel viral sequences and their potential immunological significance in healthy individuals.

Trial Locations

Locations (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China