Effect of respiratory syncytial viral infection on the microbiome of the upper respiratory tract * a controlled human infection study

Effect of respiratory syncytial viral infection on the microbiome of the upper respiratory tract * a controlled human infection study - CHIMI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51223

Enrollment

Registered

2021-07-22

Start date

2021-06-28

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchiolitis RSV respiratory tract infection

Interventions

No interventon, only viral challenge with 10E4 PFU RSV Memphis b37 viral strain

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Healthy males or females 2. Age 18-55 years 3. Signed and dated informed consent form

Exclusion criteria

Exclusion criteria: 1. Child 65 years old living in subject*s household 3. Presence of significant acute or chronic medical illness that is associated with increased risk of respiratory viral illness related complications. These include but are not limited to: a. Recent (within adulthood) history of asthma, COPD, hypertension, reactive airway disease, or any other chronic lung illness b. History or evidence of impaired immune responsivity or autoimmune disease c. Confirmed hepatitis B (HBV), human immunodeficiency virus (HIV), or hepatitis C (HCV) test

Design outcomes

Primary

Measure	Time frame
The Mean Shannon index measured in healthy subjects and in subjects after RSV infection.	—

Secondary

Measure	Time frame
Productive infection (defined as 2 positive viral detections by PCR assay on 2 consecutive sampling points during the quarantine, post RSV inoculation measured on day 2 onwards). [nasal lavage]. To characterize leukocytes pre- and post-inoculation [nasal scrape]. To determine cytokine and chemokine profile pre- and post-inoculation [nasosorption]. To measure microneutralizaion of RSV-antibodies pre and post inoculation [blood]. To measure lung function over time pre and post inoculation (FEV1, FVC, and FEF25-75) [spirometry]. To understand RSV transmission by performing RSV PCR on nasal samples from study personnel and fomites (bed, chair, clothing, doorknob and light switch) before and after wiping these surfaces with alcohol on day 4 post inoculation [(nasal) swabs]. To measure safety by self-reported and physician-reported local and systemic adverse events, and severe RSV disease defined as lower respiratory tract infection with PCR-confirmed RSV that requires hospitalization or ICU admission To measure symptom profile over time in study participants.	—

Measure

Time frame

Productive infection (defined as 2 positive viral detections by PCR assay on 2 consecutive sampling points during the quarantine, post RSV inoculation measured on day 2 onwards). [nasal lavage]. To characterize leukocytes pre- and post-inoculation [nasal scrape]. To determine cytokine and chemokine profile pre- and post-inoculation [nasosorption]. To measure microneutralizaion of RSV-antibodies pre and post inoculation [blood]. To measure lung function over time pre and post inoculation (FEV1, FVC, and FEF25-75) [spirometry]. To understand RSV transmission by performing RSV PCR on nasal samples from study personnel and fomites (bed, chair, clothing, doorknob and light switch) before and after wiping these surfaces with alcohol on day 4 post inoculation [(nasal) swabs]. To measure safety by self-reported and physician-reported local and systemic adverse events, and severe RSV disease defined as lower respiratory tract infection with PCR-confirmed RSV that requires hospitalization or ICU admission To measure symptom profile over time in study participants.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)