search
Back to results

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

Primary Purpose

Respiratory Syncytial Virus Prophylaxis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Motavizumab
Motavizumab
Motavizumab
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Prophylaxis focused on measuring MEDI-524, Motavizumab, respiratory syncytial virus, children, intravenous, Rezield

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Motavizumab, 3 mg/kg as a single intravenous dose

    Motavizumab, 15 mg/kg as a single intravenous dose

    Motavizumab, 30 mg/kg as a single intravenous dose

    Placebo, as a single intravenous dose

    Arm Description

    Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0

    Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0

    Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0

    Placebo, as a single intravenous dose administered on Day 0

    Outcomes

    Primary Outcome Measures

    Number of Subjects Reporting Adverse Events Through 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
    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
    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
    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 Outcome Measures

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

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    September 10, 2021
    Sponsor
    MedImmune LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00192504
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    January 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    MedImmune LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Syncytial Virus Prophylaxis
    Keywords
    MEDI-524, Motavizumab, respiratory syncytial virus, children, intravenous, Rezield

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Motavizumab, 3 mg/kg as a single intravenous dose
    Arm Type
    Experimental
    Arm Description
    Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
    Arm Title
    Motavizumab, 15 mg/kg as a single intravenous dose
    Arm Type
    Experimental
    Arm Description
    Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
    Arm Title
    Motavizumab, 30 mg/kg as a single intravenous dose
    Arm Type
    Experimental
    Arm Description
    Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
    Arm Title
    Placebo, as a single intravenous dose
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, as a single intravenous dose administered on Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Motavizumab
    Other Intervention Name(s)
    MEDI-524
    Intervention Description
    Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Motavizumab
    Other Intervention Name(s)
    MEDI-524
    Intervention Description
    Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Motavizumab
    Other Intervention Name(s)
    MEDI-524
    Intervention Description
    Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Single dose of placebo administered intravenously (in the vein) on Day 0
    Primary Outcome Measure Information:
    Title
    Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
    Description
    Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
    Time Frame
    From the start of treatment to 30 days after dosing
    Title
    Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
    Description
    Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
    Time Frame
    From the start of treatment to 30 days after dosing
    Title
    The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
    Description
    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
    Time Frame
    From the start of treatment to 30 days after dosing
    Title
    To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
    Description
    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).
    Time Frame
    Day 2 and Day 30
    Secondary Outcome Measure Information:
    Title
    To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
    Description
    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.
    Time Frame
    Immediately before dosing on Day 0
    Title
    To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
    Description
    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.
    Time Frame
    Day 30

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Genevieve A Losonsky, MD
    Organizational Affiliation
    MedImmune LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs