Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai

NCT06641856 | Recruiting

• 1 other identifier: 202435
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Personnel

Outcome Measures

Primary Outcomes (2)

• Virome Composition and Diversity

  Characterization of respiratory virome diversity in upper and lower respiratory tracts of healthy individuals, measured through viral sequencing of nasal, throat, and bronchoscopic samples.

  From date of inclusion until the date of final quantification, assessed up to 6 months

• Host Immune Response

  Analysis of immune-related biomarkers and gene expression in blood samples, focusing on the interaction between respiratory virome diversity and the host immune response.

  From date of inclusion until the date of final quantification, assessed up to 6 months

Secondary Outcomes (2)

• Virome and Demographic Correlation

  From date of inclusion until the date of final quantification, assessed up to 6 months

• Discovery of Unknown Viruses

  From date of inclusion until the date of final quantification, assessed up to 6 months

Study Arms (2)

Young Healthy Volunteers Group

Age Range: 20-35 years Health Status: Participants in this group must be in good overall health, as determined by medical history, physical examination, and results of a routine health check-up within the past year. Body Mass Index (BMI): Must be between 19-26 kg/m² (inclusive), with a minimum weight of 50 kg for males and 45 kg for females. Sample Size: 150 participants (including equal representation of males and females). Geographic Representation: Both permanent residents of Shanghai and non-residents who have been in the city for less than 30 days will be included. The proportion of local residents to non-residents will range from 1:1 to 2:1.

Other: Sample Collection

Elderly Healthy Volunteers Group

Age Range: 60-75 years Health Status: Participants in this group must have good respiratory health and be generally healthy based on medical history, physical examination, and a health check-up within the past year. Body Mass Index (BMI): Must be between 19-26 kg/m² (inclusive), with a minimum weight of 50 kg for males and 45 kg for females. Sample Size: 150 participants (including equal representation of males and females). Geographic Representation: Similar to the young group, the elderly group will include both permanent residents of Shanghai and non-residents, with the same proportion of local residents to non-residents (1:1 to 2:1).

Other: Sample Collection

Interventions

Sample Collection OTHER

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.

Elderly Healthy Volunteers Group; Young Healthy Volunteers Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include healthy Han Chinese individuals residing in Shanghai, divided into two age groups: young adults (20-35 years) and elderly individuals (60-75 years). A total of 300 participants will be recruited, regardless of gender. These participants will be selected based on good overall health, as determined by medical history, physical examination, and recent health checkup results.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Nasal and Pharyngeal Swabs: Two nasal swabs and three pharyngeal swabs will be collected from all 300 participants. These samples will be used for virome analysis to detect and characterize viruses present in the upper respiratory tract. 2. Peripheral Blood: From a subset of 60 participants (30 young adults and 30 elderly individuals), 10 mL of peripheral blood will be drawn using sodium citrate anticoagulant tubes. The blood samples will be centrifuged to separate plasma and blood cells. 3. Upper and Lower Respiratory Tract Samples: For the same subset of 60 participants, bronchoscopy will be performed under general anesthesia to collect respiratory tract samples from both the upper and lower airways.

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jieming Qu, Ph. D

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayang Yan, Ph. D

CONTACT

86-19821839207; yjy19960816@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)