Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai
ConditionHealth Personnel
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-75
SponsorRuijin Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sample Collection
Other interventionAll 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Young Healthy Volunteers Group1 intervention
Group B: Elderly Healthy Volunteers Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From date of inclusion until the date of final quantification, assessed up to 6 months2
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.
Time frame
From date of inclusion until the date of final quantification, assessed up to 6 monthsSecondary outcomes
1
Virome and Demographic Correlation
Analysis of the correlation between virome composition and demographic factors such as age, gender, and geographic location.
Time frame
From date of inclusion until the date of final quantification, assessed up to 6 months2
Discovery of Unknown Viruses
Identification of novel viral sequences and their potential immunological significance in healthy individuals.
Time frame
From date of inclusion until the date of final quantification, assessed up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov