TINO: Identifying the Underlying Mechanisms and Consequences of the Loss of Nasal T Cells in Vital and Frail Older Individuals

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ •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

• 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

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Simon P Jochems, PhD
s.p.jochems@lumc.nl
+31715261328
Time Frame
Start Date: 2021-01-24
Estimated Completion Date: 2026-05
Participants
Target number of participants: 170
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov