bronchiolitis RSV respiratory tract infection
Conditions
Interventions
Study A: No intervention, only viral challenge.
Study B: 0,2mL nose drops per nostril (1mg/mL palivizumab or placebo)
administered one time each as a prophylaxis 2 hours before the viral challenge
Sponsors
Universitair Medisch Centrum Utrecht
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: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study A: 1. Productive infection (defined as 2 positive viral detections by PCR assay on 2 consecutive sampling points during the quarantine, post RSV inoculation). Study B will start if there is productive infection in 2/6 volunteers in Study A and there are no serious adverse events related to viral inoculation. See detailed protocol for transition to Study B if these criteria are not met. Study B: 1. Area under the curve (AUC) for viral load as determined by quantitative PCR from a daily nasal-wash sample from day 2 to day 14 similar to previous studies (Devincenzo NEJM 2014, Devincenzo NEJM 2015). | — |
Secondary
| Measure | Time frame |
|---|---|
| Study A: Safety measured by self-reported and physician-reported local and systemic adverse events; transmission of RSV to healthcare workers and fomites Study B: Safety, pharmacokinetics, lung function over time, anti-drug antibodies, immunologic endpoints (cytokines and leucocytes) | — |
Countries
Netherlands
Outcome results
None listed