ImmunosenescenceNCT07672522
Exploratory Study on Infection and Immunosenescence Based on an Elderly Clinical Cohort
An observational study of Immunosenescence, run by Huashan Hospital at 1 site in China.
Trial summary
This prospective observational cohort study aims to investigate the relationship between immunosenescence and infectious diseases in older adults. Individuals aged 60 years and older, including elderly patients with infections and healthy controls, will be enrolled and followed longitudinally. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence
- How many people
- 484 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2024to 30 Oct 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 60 years and older
Who may be able to join
- No clinical symptoms suggestive of infection, including fever, cough, dyspnea, fatigue, or myalgia.
- No abnormal physical signs, including lymphadenopathy, hepatomegaly, splenomegaly, or skin rash.
- Normal laboratory test results, including complete blood count (CBC), C-reactive protein (CRP), and liver and renal function tests.
- Healthy adults without underlying chronic diseases, no history of infectious diseases within the previous 6 months, and generally normal cognitive function.
- Male or female.
- Able to understand the study procedures and voluntarily provide written informed consent.
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- Inclusion Criteria for the Infection Group 1.Age: 60 years or older; no gender restrictions. 2. Clinically diagnosed with an infectious disease by the treating physician. 3. The participant provides informed consent and signs the relevant documents.
- -------------- Exclusion Criteria for the Healthy Control Group
- Refusal to participate in the study;
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
Who cannot join
- Final primary diagnosis is a non-infectious disease (e.g., connective tissue disease, tumor, or other conditions).
- Positive culture results are determined by the clinician to be due to colonization or contamination rather than infection.
- Refusal to participate in the study.
- Patients in critical or severe conditions who are unable to cooperate with sample collection.
- Other conditions deemed unsuitable for inclusion as determined by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Jingwen Ai, MD, 86+13764990804, jingwenai1990@126.com
About this study
This prospective observational cohort study aims to investigate the relationship between immunosenescence and infectious diseases in older adults. Individuals aged 60 years and older, including elderly patients with infections and healthy controls, will be enrolled and followed longitudinally.
Clinical information, laboratory test results, and health assessment data will be collected. Biological specimens, including peripheral blood, urine, stool, sputum, and nasopharyngeal swabs, will be obtained during enrollment and follow-up. Participants will undergo regular assessments of health status, infection events, and aging-related clinical characteristics.
Read more
The study will evaluate age-related changes in immune function, immune cell composition, immune receptor repertoires, epigenetic characteristics, metabolic profiles, and respiratory and gut microbiota. By integrating clinical and multi-omics data, the study aims to identify biomarkers associated with immunosenescence, susceptibility to infection, disease severity, and clinical outcomes in older adults.
The results are expected to improve understanding of the mechanisms linking aging, immune dysfunction, and infectious diseases, and to support the development of predictive models and preventive strategies for infection management and healthy aging in elderly populations.
- Conditions
- Immunosenescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infected Older Adults | Elderly participants aged 60 years or older who meet the study criteria for infectious diseases at enrollment or during the study follow-up period. | |
| Healthy Older Controls | Adults aged 60 years or older who are living independently or receiving routine health examinations and have no evidence of active infection at enrollment or during the study follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of peripheral immune cell subset
Proportion of peripheral blood immune cell subsets in the infection group versus the healthy control group.
Measured: Baseline to 5 years
Secondary outcomes (3)
DNA methylation level
Chromatin accessibility of peripheral blood mononuclear cells.
Measured: Baseline to 5 years
Metabolite abundance (metabolomic profiling)
Abundance of metabolites in plasma and urine.
Measured: Baseline to 5 years
Respiratory and gut microbiota diversity measured by microbiome sequencing
Diversity of respiratory tract and gut microbiota, measured by microbiome sequencing and reported as the Shannon diversity index.
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start29 Nov 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosenescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 484 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingwen Ai, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672522
- Sponsor's protocol ID
- KY2024-1177
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Infection and Immunosenescence Based on an Elderly Clinical Cohort
- ClinicalTrials.gov ID
- NCT07672522
- Acronym / sponsor ID
- KY2024-1177
- Conditions
- Immunosenescence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational cohort study aims to investigate the relationship between immunosenescence and infectious diseases in older adults. Individuals aged 60 years and older, including elderly patients with infections and healthy controls, will be enrolled and followed longitudinally.
Clinical information, laboratory test results, and health assessment data will be collected. Biological specimens, including peripheral blood, urine, stool, sputum, and nasopharyngeal swabs, will be obtained during enrollment and follow-up. Participants will undergo regular assessments of health status, infection events, and aging-related clinical characteristics.
The study will evaluate age-related changes in immune function, immune cell composition, immune receptor repertoires, epigenetic characteristics, metabolic profiles, and respiratory and gut microbiota. By integrating clinical and multi-omics data, the study aims to identify biomarkers associated with immunosenescence, susceptibility to infection, disease severity, and clinical outcomes in older adults.
The results are expected to improve understanding of the mechanisms linking aging, immune dysfunction, and infectious diseases, and to support the development of predictive models and preventive strategies for infection management and healthy aging in elderly populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infected Older Adults | – | –Elderly participants aged 60 years or older who meet the study criteria for infectious diseases at enrollment or during the study follow-up period. |
| Healthy Older Controls | – | –Adults aged 60 years or older who are living independently or receiving routine health examinations and have no evidence of active infection at enrollment or during the study follow-up period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 60 years and older
Key inclusion criteria (10 listed)
- No clinical symptoms suggestive of infection, including fever, cough, dyspnea, fatigue, or myalgia.
- No abnormal physical signs, including lymphadenopathy, hepatomegaly, splenomegaly, or skin rash.
- Normal laboratory test results, including complete blood count (CBC), C-reactive protein (CRP), and liver and renal function tests.
- Healthy adults without underlying chronic diseases, no history of infectious diseases within the previous 6 months, and generally normal cognitive function.
- Male or female.
Key exclusion criteria (5 listed)
- Final primary diagnosis is a non-infectious disease (e.g., connective tissue disease, tumor, or other conditions).
- Positive culture results are determined by the clinician to be due to colonization or contamination rather than infection.
- Refusal to participate in the study.
- Patients in critical or severe conditions who are unable to cooperate with sample collection.
- Other conditions deemed unsuitable for inclusion as determined by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of peripheral immune cell subset
Time frame: Baseline to 5 years
Proportion of peripheral blood immune cell subsets in the infection group versus the healthy control group.
3 secondary outcomes
DNA methylation level
Time frame: Baseline to 5 years
Metabolite abundance (metabolomic profiling)
Time frame: Baseline to 5 years
Respiratory and gut microbiota diversity measured by microbiome sequencing
Time frame: Baseline to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosenescence, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Ai, MD (86+13764990804, jingwenai1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of peripheral immune cell subset (time frame: Baseline to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.