Completed

NCT Number: NCT00192504

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

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).

Completed

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Key information

Conditions

Respiratory Syncytial Virus Prophylaxis

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motavizumab

Biological

Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0

Other names: MEDI-524

Placebo

Other

Single dose of placebo administered intravenously (in the vein) on Day 0

Primary outcomes

Number of Subjects Reporting Adverse Events Through 30 Days After Dosing

Time frame: 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

Time frame: 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
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations

Time frame: 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
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30

Time frame: 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).

Secondary outcomes

To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0

Time frame: 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.
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30

Time frame: 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.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 19, 2005
Registry last updated: Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.