Clinical trial NCT06641856: Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai
Official title: Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health Personnel
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Virome Composition and Diversity
timeFrame: From date of inclusion until the date of final quantification, assessed up to 6 months
measure: Host Immune Response
timeFrame: From date of inclusion until the date of final quantification, assessed up to 6 months
Secondary outcomes:
measure: Virome and Demographic Correlation
timeFrame: From date of inclusion until the date of final quantification, assessed up to 6 months
measure: Discovery of Unknown Viruses
timeFrame: From date of inclusion until the date of final quantification, assessed up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Jieming Qu, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: