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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54420

Enrollment

Registered

2021-08-11

Start date

2022-08-12

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

Study A: No intervention, only viral challenge. Study B: 0,1mL nose drops per nostril (1mg/mL palivizumab or placebo) administered one time each as a prophylaxis 2 hours before the viral challenge

Eligibility

Age

18 Years to 64 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 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

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 1/6 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).	—

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 1/6 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 leukocytes)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)