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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192478
First received: September 13, 2005
Last updated: July 24, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Respiratory Syncytial Virus Infections
Biological: Medi-524
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

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 [ Time Frame: 30 days after patient's final dose of study drug ]
  • Pharmacokinetics of MEDI-524 [ Time Frame: · Serum concentrations at each data collection visit will be summarized ]

Secondary Outcome Measures:
  • Immunogenicity of MEDI-524 [ Time Frame: · Serum ELISA binding activity at each data collection visit will be summarized ]

Enrollment: 217
Study Start Date: February 2004
Study Completion Date: August 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
MEDI-524
Biological: Medi-524
IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals

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.

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192478

Locations
Argentina
Hospital General de Niños "Ricardo Gutierrez"
Buenos Aires, Argentina, 1330
Hospital Interzonal General de Agudos "Dr. Diego Paroissien
Buenos Aires, Argentina, 5975
Chile
Hospital Clinico Pontificia Universidad Catolica de Chile
Santiago, Chile
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Genevieve Losonsky, MD MedImmune LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192478     History of Changes
Other Study ID Numbers: MI-CP104
Study First Received: September 13, 2005
Last Updated: July 24, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 17, 2014