Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection - a controlled human infection study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

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

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study: 1. Child younger than 3 years old living in
subject*s household 2. Person older than 65 years old or significant primary or
secondary immunodeficiency living in subjects 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 4. Adults with a nasal cold or obstructions which could interfere
with administration of the study intervention 5. Simultaneous use of other
nasal drops, sprays, or medications 6. Nasal surgery prior to or during the
trial 7. Positive COVID-test 48 hours prior to start of the study 8. Pregnancy
9. Symptoms of clear nasal congestion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study A:<br /><br>1. Productive infection (defined as 2 positive viral detections by PCR assay on<br /><br>2 consecutive sampling points during the quarantine, post RSV inoculation).<br /><br>Study B will start if there is productive infection in 1/6 volunteers in Study<br /><br>A and there are no serious adverse events related to viral inoculation. See<br /><br>detailed protocol for transition to Study B if these criteria are not met.<br /><br>Study B:<br /><br>1. Area under the curve (AUC) for viral load as determined by quantitative PCR<br /><br>from a daily nasal-wash sample from day 2 to day 14 similar to previous studies<br /><br>(Devincenzo NEJM 2014, Devincenzo NEJM 2015).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Study A: Safety measured by self-reported and physician-reported local and<br /><br>systemic adverse events; transmission of RSV to healthcare workers and fomites<br /><br>Study B: Safety, pharmacokinetics, lung function over time, anti-drug<br /><br>antibodies, immunologic endpoints (cytokines and leukocytes)</p><br>