Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection * a human challenge study

Phase 2

Withdrawn

Conditions: bronchiolitis
RSV respiratory tract infection
10047438
10024970

Registration Number: NL-OMON55009

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

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 <3 years old living in subject*s household
2. 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
3. Adults with a nasal cold or obstructions which could interfere with
administration of the study intervention
4. Simultaneous use of other nasal drops, sprays, or medications
5. Nasal surgery prior to or during the trial
6. Positive COVID-test <48 hours prior to start of the study

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 2/6 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 leucocytes) </p><br>