Respiratory Virome Diversity and Baseline Immunity in Healthy Individuals in Shanghai

October 25, 2024 updated by: Jieming QU, Ruijin Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Virome Composition and Diversity
Time Frame: 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.
From date of inclusion until the date of final quantification, assessed up to 6 months
Host Immune Response
Time Frame: 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.
From date of inclusion until the date of final quantification, assessed up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Virome and Demographic Correlation
Time Frame: 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.
From date of inclusion until the date of final quantification, assessed up to 6 months
Discovery of Unknown Viruses
Time Frame: 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.
From date of inclusion until the date of final quantification, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jieming Qu, Ph. D, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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