Prospective cohort study of respiratory viral infections and mucosal immune responses in community-dwelling adults >= 65 years old

Withdrawn

Conditions: airway infections
respiratory viral infections
10047438

Registration Number: NL-OMON51646

Lead Sponsor: Julius Clinical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 111

Inclusion Criteria

1. Aged 65 years or older
2. Cognitive competence such that one understands the study concept and
requirements, can make a voluntary decision to participate in the study, and
give informed consent
3. Willing and able to complete the study procedures
4. Giving informed consent
5. Having access to a mobile phone or landline phone
6. Generally healthy and without chronic disease that would likely require
hospitalisation during the course of the study, as per the investigator*s
clinical judgment

Exclusion Criteria

1. Residing in a short- or long-term care facility
2. Having a terminal illness, as judged by the investigator
3. Receiving anti-cancer treatment
4. Having a B-cell disorder or blood or bleeding disorder, including anaemia,
haemophilia, Factor II, V, VII, X, or XII deficiencies, Von Willebrand*s
disease, tendency to bruise easily, blood cancer, taking blood thinners, or
otherwise unable to give blood
5. Being a regular blood donor
6. Any known factor, condition, or disease that might interfere with
compliance, study conduct or interpretation of the results, as deemed by the
investigator

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Incidence of pauci-symptomatic and symptomatic influenza-like illness/acute<br /><br>respiratory illness (ILI/ARI) episodes due to influenza virus, SARS-CoV-2 or<br /><br>RSV (see Definitions) based on clinical symptoms and laboratory-based multiplex<br /><br>PCR testing of nasopharyngeal/throat swabs collected at the time of infection<br /><br>- Incidence and aetiology of co-infections in pauci-symptomatic and symptomatic<br /><br>laboratory-confirmed influenza, SARS-CoV-2, or RSV<br /><br>- Occurrence of re-infections with influenza, SARS-CoV-2, or RSV.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Immunological and molecular characteristics of upper respiratory tract<br /><br>samples, including nasal swabs, nasosorption samples and saliva samples<br /><br>collected from subjects whilst having a PCR-confirmed pauci-symptomatic or<br /><br>symptomatic infection (ILI/ARI) caused by influenza virus,<br /><br>SARS-CoV-2, or RSV, or when infection free (no symptoms and no virus detected<br /><br>in PCR)<br /><br>- Serum IgG and saliva IgA, IgG and IgM antibody responses against different<br /><br>respiratory viruses including influenza virus, SARS-CoV-2 and RSV at baseline<br /><br>and over the course of the study including pauci-symptomatic and symptomatic<br /><br>ILI/ARI episodes</p><br>