Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

Phase 1

Completed

• Conditions: Respiratory Syncytial Virus Prophylaxis
• Interventions: Biological: Motavizumab; Other: Placebo

• Registration Number: NCT00192504
• Lead Sponsor: MedImmune LLC

Brief Summary

The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).

Detailed Description

This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Status Verified: 2006-10
• Results First Submitted: 2021-09-10
• Results First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Results First Posted: 2021-10-08
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Previously healthy
• Age 24 months and younger at the time of randomization
• Gestational age of 36 weeks gestation and older
• Randomization within 24 hours after hospitalization
• Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization

Exclusion Criteria

• Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
• Required intubation for ventilatory support
• Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
• Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
• Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
• Mechanical ventilation at any time prior to the onset of the current RSV infection
• Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
• Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
• Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
• Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
• Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motavizumab, 3 mg/kg as a single intravenous dose	Motavizumab	Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
Motavizumab, 15 mg/kg as a single intravenous dose	Motavizumab	Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
Placebo, as a single intravenous dose	Placebo	Placebo, as a single intravenous dose administered on Day 0
Motavizumab, 30 mg/kg as a single intravenous dose	Motavizumab	Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0

Primary Outcome Measures

Name	Time	Method
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30	Day 2 and Day 30	Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations	From the start of treatment to 30 days after dosing	Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing	From the start of treatment to 30 days after dosing	Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing	From the start of treatment to 30 days after dosing	Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing

Secondary Outcome Measures

Name	Time	Method
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30	Day 30	The serum anti-motavizumab antibody titers were measured in subjects on Day 30. Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0	Immediately before dosing on Day 0	The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing). Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.