TINO: T Cells in the Nose of Older Adults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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".

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

170 Participants
are grouped into 3 trial groups
Group A: Young adults
Group B: Vital elderly
Group C: Frail elderly

Trial outcomes

Primary outcomes

1

Frequency of nasal CD8+ T cells in young adults and frail older adults.

CD8 T cells relative to nasal epithelial cells (ratio)

Time frame
baseline sample or month 3 sample

Secondary outcomes

1

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

Time frame
baseline sample or month 3 sample
2

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

Time frame
baseline sample or month 3 sample
3

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

Time frame
baseline sample or month 3 sample
4

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

Time frame
baseline sample or month 3 sample

Other outcomes

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