Clinical trial NCT00192504: Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Prophylaxis
Keywords: MEDI-524
Motavizumab
respiratory syncytial virus
children
intravenous
Rezield
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 31
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
timeFrame: From the start of treatment to 30 days after dosing
measure: Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
timeFrame: From the start of treatment to 30 days after dosing
measure: The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
timeFrame: From the start of treatment to 30 days after dosing
measure: To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
timeFrame: Day 2 and Day 30
Secondary outcomes:
measure: To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
timeFrame: Immediately before dosing on Day 0
measure: To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
timeFrame: Day 30
Other outcomes:
Locations:
Study officials:
affiliation: MedImmune LLC
name: Genevieve A Losonsky, MD
role: STUDY_DIRECTOR
References: