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

September 10, 2021 updated by: MedImmune LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motavizumab, 3 mg/kg as a single intravenous dose
Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
Biological: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Biological: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Biological: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Experimental: Motavizumab, 15 mg/kg as a single intravenous dose
Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
Biological: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Biological: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Biological: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Experimental: Motavizumab, 30 mg/kg as a single intravenous dose
Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
Biological: Motavizumab
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Biological: Motavizumab
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Biological: Motavizumab
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Other Names:
  • MEDI-524
Placebo Comparator: Placebo, as a single intravenous dose
Placebo, as a single intravenous dose administered on Day 0
Other: Placebo
Single dose of placebo administered intravenously (in the vein) on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the start of treatment to 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
From the start of treatment to 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
From the start of treatment to 30 days after 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).
Day 2 and Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately before dosing on Day 0
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.
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: Genevieve A Losonsky, MD, MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-CP106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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