Respiratory Tract InfectionsTINONCT06039527
TINO: T Cells in the Nose of Older Adults
An observational study of Respiratory Tract Infections and Aging, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring lower respiratory tract infections. Besides calendar age, the degree of frailty also associates with increased susceptibility to pneumonia requiring hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Aging
- How many people
- 125 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2021to 10 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population: Investigators will recruit participants from 3 groups: * healthy young adults (18-30 years, n=50) * vital older adults (>65 years, n=60) * frail elderly (>65 years, n=60). These will be consist of individuals without a history of recurrent respiratory infections or with >2 self-reported episodes of respiratory infection in the past year. Frailty will be determined by a clinical frailty score. The Clinical Frailty Scale (CFS) is a scale that caretakers can use to identify level of frailty in older patients from 1 (very fit) through 9 (terminally ill). For the present study, "vital older patients" are defined as those with a CFS of 1-3 and "older patients living with frailty with a CFS of 4 or higher".
Who may be able to join
- •Adults able and willing to provide informed consent.
- Specific inclusion criteria per group:
- Young adults aged 18-30 years old
- Healthy elderly aged >65 years old
- Frail elderly >65 years old
- Clinical Frailty score healthy elderly 1-3
Show all 9Show fewer
- Clinical Frailty score frail elderly >3
- Self-reported respiratory tract infection in previous year healthy elderly 0-1
- Self-reported respiratory tract infection in previous year frail elderly 0-1 or >1
Who cannot join
- Incompetence to provide informed consent prior or during study
- Current smoker or >40 pack year history
- History of severe nose bleedings
- Diagnosed with asthma, COPD or chronic rhinosinusitis
- Use of inhalation corticosteroids or antibiotics in the past 6 weeks
- Current use of anti-coagulants (to prevent nosebleeds). Platelet inhibitors like acetylsalicylzuur (Ascal) are allowed.
Show all 10Show fewer
- Respiratory tract infection or common cold in the past 2 weeks
- Immunocompromised individuals (with primary immune deficiency or secondary immune deficiency)
- Life expectancy <28 days in the opinion of study physician
- Vaccination in the 2 months prior to study start. A potential subject that is only excluded from participation based on a recent vaccination will be asked to re-participate 2 months post vaccination.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
Official title: TINO: Identifying the Underlying Mechanisms and Consequences of the Loss of Nasal T Cells in Vital and Frail Older Individuals
Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring lower respiratory tract infections. Besides calendar age, the degree of frailty also associates with increased susceptibility to pneumonia requiring hospitalization. How alterations in the mucosal immune system with advanced age predispose to infections remains unclear as access to relevant tissue samples is limited. With minimally-invasive nasal sampling methods, it was recently observed that in vital older adults, both CD4+ T cells and CD8+ T cells are selectively lost from the nasal mucosa. However, the exact phenotype, underlying mechanisms, key molecules and consequences of this have not yet been investigated.
Objective:
Read more
Elucidate the mechanisms underlying the loss of nasal T cells and characterize in depth the differences of T cells in young and older adults and associate this loss with susceptibility to infections.
Study design: Prospective cohort study
Study population: Participants will be recruited from 3 groups:
- healthy young adults (18-30 years, n=50)
- vital older adults (>65 years, n=60)
- frail elderly (>65 years, n=60). This group includes individuals without a history of recurrent respiratory infections or with >2 self-reported episodes of respiratory infection in the past year.
Main study parameters/endpoints: Frequency of nasal CD8+ T cells in young adults and frail older adults.
Secondary study parameters/endpoints:
- Phenotype (subsets, activation status), functionality, transcriptomic state, clonality and frequency of nasal and blood T cell populations
- Stability of T cells and other immune parameters, as described for main study parameter, during a second sample after 3 months.
- Analysis of other immune populations as for main study parameter
- Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their association with T cells and other immune populations
- Respiratory tract microbiota profiles and presence of asymptomatic viral infections and their association with T cells and other immune parameters
- Chronological and biological age, sex, and other immunologically relevant parameters with T cell populations and other immune parameters
- Alteration of T cell phenotype, during and following respiratory tract infections. Levels of antigen-specific T cells and other immune parameters in nose and blood post infection.
- Conditions
- Respiratory Tract Infections, Aging
- Medical subject headings
- Respiratory Tract Infections
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 |
|---|---|---|
| Young adults | N=50 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset | |
| Vital elderly | N=60 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset | |
| Frail elderly | N=60 of this group. Half with recurring respiratory infections, and half without No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of nasal CD8+ T cells in young adults and frail older adults.
CD8 T cells relative to nasal epithelial cells (ratio)
Measured: baseline sample or month 3 sample
Secondary outcomes (16)
Phenotype of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
percentage of T cells and T cell subsets
Measured: baseline sample or month 3 sample
Functionality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
percentage of T cells responding to in vitro stimulations
Measured: baseline sample or month 3 sample
Transcriptomic cluster composition of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not, as frequency of T cell subsets.
T cell clusters based on gene expression patterns
Measured: baseline sample or month 3 sample
Clonality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
Number and proportion of TCR clones
Measured: baseline sample or month 3 sample
Stability of nasal T cells, as described for main study parameter, during a second sample after 3 months.
CD8 T cells relative to nasal epithelial cells (ratio)
Measured: baseline sample versus month 3 sample
Stability of nasal immune populations, during a second sample after 3 months.
immune cell populations relative to nasal epithelial cells (ratio)
Measured: baseline sample versus month 3 sample
Comparison of nasal immune cell populations between young adults, vital and frail elderly
ratio to epithelial cells
Measured: baseline sample or month 3 sample
Comparison of peripheral immune cell populations between young adults, vital and frail elderly
percentage of total CD45+ cells
Measured: baseline sample or month 3 sample
Concentration of nasal and systemic cytokines
concentrations
Measured: baseline sample or month 3 sample
Concentration of nasal and systemic metabolitesother immune populations
concentrations
Measured: baseline sample or month 3 sample
Respiratory tract microbiota profiles and their association with T cells and other immune parameters
microbiota abundance (total sum scaling)
Measured: baseline sample or month 3 sample
Presence of asymptomatic viral infections and their association with T cells and other immune parameters
viral of loads (Ct)
Measured: baseline sample or month 3 sample
Effect of sex on aging effects of nasal immune populations
ratio to nasal epithelial cells
Measured: baseline sample or month 3 sample
Effect of sex on aging effects of blood immune populations
percentage of CD45+ cells
Measured: baseline sample or month 3 sample
Frequencies of antigen-specific T cells in nose post infection.
antigen-specific T cells as percentage of T cells
Measured: symptom onset and 1, 3 and 5 months later
Frequencies of antigen-specific T cells in blood post infection.
antigen-specific T cells as percentage of T cells
Measured: symptom onset and 1, 3 and 5 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start24 Jan 2021
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Why it stopped: We were not able to recruit sufficient older adults with frailty and therefore stopped the study prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon P Jochems, PhD, Leiden University Medical Center
- Investigators
- Simon P Jochems, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039527
- Sponsor's protocol ID
- P21.066
- Other IDs
- NL77841.058.21
- Acronym
- TINO
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As even pseudonymized data is considered personal data as these can sometimes be traced back to an individual, data can be requested from the PI. If requests fall within the scope of the informed consent and study protocol, an MTA/DTA can be shared. Data will be posted on repositories with restricted access.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TINO: Identifying the Underlying Mechanisms and Consequences of the Loss of Nasal T Cells in Vital and Frail Older Individuals
- ClinicalTrials.gov ID
- NCT06039527
- Acronym / sponsor ID
- TINO / P21.066
- Conditions
- Respiratory Tract Infections, Aging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We were not able to recruit sufficient older adults with frailty and therefore stopped the study prematurely
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 15 Sep 2023 (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.
Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring lower respiratory tract infections. Besides calendar age, the degree of frailty also associates with increased susceptibility to pneumonia requiring hospitalization. How alterations in the mucosal immune system with advanced age predispose to infections remains unclear as access to relevant tissue samples is limited. With minimally-invasive nasal sampling methods, it was recently observed that in vital older adults, both CD4+ T cells and CD8+ T cells are selectively lost from the nasal mucosa. However, the exact phenotype, underlying mechanisms, key molecules and consequences of this have not yet been investigated.
Objective:
Elucidate the mechanisms underlying the loss of nasal T cells and characterize in depth the differences of T cells in young and older adults and associate this loss with susceptibility to infections.
Study design: Prospective cohort study
Study population: Participants will be recruited from 3 groups:
- healthy young adults (18-30 years, n=50)
- vital older adults (>65 years, n=60)
- frail elderly (>65 years, n=60). This group includes individuals without a history of recurrent respiratory infections or with >2 self-reported episodes of respiratory infection in the past year.
Main study parameters/endpoints: Frequency of nasal CD8+ T cells in young adults and frail older adults.
Secondary study parameters/endpoints:
- Phenotype (subsets, activation status), functionality, transcriptomic state, clonality and frequency of nasal and blood T cell populations
- Stability of T cells and other immune parameters, as described for main study parameter, during a second sample after 3 months.
- Analysis of other immune populations as for main study parameter
- Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their association with T cells and other immune populations
- Respiratory tract microbiota profiles and presence of asymptomatic viral infections and their association with T cells and other immune parameters
- Chronological and biological age, sex, and other immunologically relevant parameters with T cell populations and other immune parameters
- Alteration of T cell phenotype, during and following respiratory tract infections. Levels of antigen-specific T cells and other immune parameters in nose and blood post infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | –N=50 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset |
| Vital elderly | – | –N=60 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset |
| Frail elderly | – | –N=60 of this group. Half with recurring respiratory infections, and half without No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population: Investigators will recruit participants from 3 groups: * healthy young adults (18-30 years, n=50) * vital older adults (>65 years, n=60) * frail elderly (>65 years, n=60). These will be consist of individuals without a history of recurrent respiratory infections or with >2 self-reported episodes of respiratory infection in the past year. Frailty will be determined by a clinical frailty score. The Clinical Frailty Scale (CFS) is a scale that caretakers can use to identify level of frailty in older patients from 1 (very fit) through 9 (terminally ill). For the present study, "vital older patients" are defined as those with a CFS of 1-3 and "older patients living with frailty with a CFS of 4 or higher".
Key inclusion criteria (9 listed)
- •Adults able and willing to provide informed consent.
- Young adults aged 18-30 years old
- Healthy elderly aged >65 years old
- Frail elderly >65 years old
- Clinical Frailty score healthy elderly 1-3
Key exclusion criteria (10 listed)
- Incompetence to provide informed consent prior or during study
- Current smoker or >40 pack year history
- History of severe nose bleedings
- Diagnosed with asthma, COPD or chronic rhinosinusitis
- Use of inhalation corticosteroids or antibiotics in the past 6 weeks
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
Frequency of nasal CD8+ T cells in young adults and frail older adults.
Time frame: baseline sample or month 3 sample
CD8 T cells relative to nasal epithelial cells (ratio)
16 secondary outcomes
Phenotype of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
Time frame: baseline sample or month 3 sample
Functionality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
Time frame: baseline sample or month 3 sample
Transcriptomic cluster composition of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not, as frequency of T cell subsets.
Time frame: baseline sample or month 3 sample
Clonality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
Time frame: baseline sample or month 3 sample
Stability of nasal T cells, as described for main study parameter, during a second sample after 3 months.
Time frame: baseline sample versus month 3 sample
Stability of nasal immune populations, during a second sample after 3 months.
Time frame: baseline sample versus month 3 sample
Comparison of nasal immune cell populations between young adults, vital and frail elderly
Time frame: baseline sample or month 3 sample
Comparison of peripheral immune cell populations between young adults, vital and frail elderly
Time frame: baseline sample or month 3 sample
Concentration of nasal and systemic cytokines
Time frame: baseline sample or month 3 sample
Concentration of nasal and systemic metabolitesother immune populations
Time frame: baseline sample or month 3 sample
Respiratory tract microbiota profiles and their association with T cells and other immune parameters
Time frame: baseline sample or month 3 sample
Presence of asymptomatic viral infections and their association with T cells and other immune parameters
Time frame: baseline sample or month 3 sample
Effect of sex on aging effects of nasal immune populations
Time frame: baseline sample or month 3 sample
Effect of sex on aging effects of blood immune populations
Time frame: baseline sample or month 3 sample
Frequencies of antigen-specific T cells in nose post infection.
Time frame: symptom onset and 1, 3 and 5 months later
Frequencies of antigen-specific T cells in blood post infection.
Time frame: symptom onset and 1, 3 and 5 months later
Results and safety
The study was stopped early (reason given: We were not able to recruit sufficient older adults with frailty and therefore stopped the study prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. As even pseudonymized data is considered personal data as these can sometimes be traced back to an individual, data can be requested from the PI. If requests fall within the scope of the informed consent and study protocol, an MTA/DTA can be shared. Data will be posted on repositories with restricted access.
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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. This study is not recruiting at the moment.
Simon P Jochems, PhD principal investigator
LUMC
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 Respiratory Tract Infections and Aging, run by Leiden University Medical Center at 1 site in Netherlands.
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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Jul 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 Netherlands. 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?
The study was stopped early (reason given: We were not able to recruit sufficient older adults with frailty and therefore stopped the study prematurely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of nasal CD8+ T cells in young adults and frail older adults. (time frame: baseline sample or month 3 sample). 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 7 Jul 2026.