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Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Medi-524
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

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

Inclusion Criteria: All male or female children must have met all the following criteria: [Groups 1, 2, and 3] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-month birthday) or [Group 3 only] The child must have been £24 months of age at the time of entry into the study (child must have been entered on or before their 24-month birthday) and diagnosed with BPD, with stable or decreasing doses of diuretics, steroids, or bronchodilators within the previous 6 months The child must have been in general good health at the time of entry The child's parent or legal guardian must have provided written informed consent; and The child must have been able to complete the follow-up visits through 90 days following last injection of MEDI-524 Parent/legal guardian of patient must have had available telephone access Exclusion Criteria: Children must have had none of the following: Hospitalization at the time of study entry (unless discharge was expected within 3 days after entry into the study) [All children in Groups 1 and 2; only children £6 months of age in Group 3] Birth hospitalization >6 weeks duration or [Only children >6 months of age in Group 3] Birth hospitalization >12 weeks duration Been receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including CPAP) [Groups 1 and 2 only] Diagnosis of BPD, defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days Congenital heart disease (CHD) (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled) Evidence of infection with hepatitis A, B, or C virus Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection Mother with known HIV infection Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine >1.5´ the upper limit of normal for age; AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age; hemoglobin <9.5 gm/dL; white blood cell count <4,000 cells/mm3; platelet count <120,000 cells/mm3 Acute illness or progressive clinical disorder Active infection, including acute RSV infection Previous reaction to IGIV, blood products, or other foreign proteins Have ever received palivizumab Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGamÒ], IVIG), or any investigational agents Currently participating in any investigational study Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.

Sites / Locations

  • Hospital General de Niños "Ricardo Gutierrez"
  • Hospital Interzonal General de Agudos "Dr. Diego Paroissien
  • Hospital Clinico Pontificia Universidad Catolica de Chile

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

MEDI-524

Outcomes

Primary Outcome Measures

Describe the safety and tolerability of repeated IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals in children at risk for serious RSV disease
Pharmacokinetics of MEDI-524

Secondary Outcome Measures

Immunogenicity of MEDI-524

Full Information

First Posted
September 13, 2005
Last Updated
July 24, 2008
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00192478
Brief Title
Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524
Official Title
A Phase 1/2, Open-Label, Repeat-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children at Risk for Serious RSV Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

Brief Summary
MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.
Detailed Description
This study is designed to describe the safety, tolerability, immunogenicity, and pharmacokinetics of escalating, repeated IM injections (the intended route of administration for immunoprophylaxis) of MEDI-524, initially in children £6 months old with a history of prematurity (³32 to £35 weeks gestation, without BPD), one of the target populations of infants at high risk for serious RSV disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
MEDI-524
Intervention Type
Biological
Intervention Name(s)
Medi-524
Intervention Description
IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals
Primary Outcome Measure Information:
Title
Describe the safety and tolerability of repeated IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals in children at risk for serious RSV disease
Time Frame
30 days after patient's final dose of study drug
Title
Pharmacokinetics of MEDI-524
Time Frame
· Serum concentrations at each data collection visit will be summarized
Secondary Outcome Measure Information:
Title
Immunogenicity of MEDI-524
Time Frame
· Serum ELISA binding activity at each data collection visit will be summarized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All male or female children must have met all the following criteria: [Groups 1, 2, and 3] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-month birthday) or [Group 3 only] The child must have been £24 months of age at the time of entry into the study (child must have been entered on or before their 24-month birthday) and diagnosed with BPD, with stable or decreasing doses of diuretics, steroids, or bronchodilators within the previous 6 months The child must have been in general good health at the time of entry The child's parent or legal guardian must have provided written informed consent; and The child must have been able to complete the follow-up visits through 90 days following last injection of MEDI-524 Parent/legal guardian of patient must have had available telephone access Exclusion Criteria: Children must have had none of the following: Hospitalization at the time of study entry (unless discharge was expected within 3 days after entry into the study) [All children in Groups 1 and 2; only children £6 months of age in Group 3] Birth hospitalization >6 weeks duration or [Only children >6 months of age in Group 3] Birth hospitalization >12 weeks duration Been receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including CPAP) [Groups 1 and 2 only] Diagnosis of BPD, defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days Congenital heart disease (CHD) (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled) Evidence of infection with hepatitis A, B, or C virus Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection Mother with known HIV infection Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine >1.5´ the upper limit of normal for age; AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age; hemoglobin <9.5 gm/dL; white blood cell count <4,000 cells/mm3; platelet count <120,000 cells/mm3 Acute illness or progressive clinical disorder Active infection, including acute RSV infection Previous reaction to IGIV, blood products, or other foreign proteins Have ever received palivizumab Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGamÒ], IVIG), or any investigational agents Currently participating in any investigational study Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genevieve Losonsky, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General de Niños "Ricardo Gutierrez"
City
Buenos Aires
ZIP/Postal Code
1330
Country
Argentina
Facility Name
Hospital Interzonal General de Agudos "Dr. Diego Paroissien
City
Buenos Aires
ZIP/Postal Code
5975
Country
Argentina
Facility Name
Hospital Clinico Pontificia Universidad Catolica de Chile
City
Santiago
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524

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