Clinical trial NCT00192478: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 217
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 30 days after patient's final dose of study drug
measure: Pharmacokinetics of MEDI-524
timeFrame: · Serum concentrations at each data collection visit will be summarized
Secondary outcomes:
measure: Immunogenicity of MEDI-524
timeFrame: · Serum ELISA binding activity at each data collection visit will be summarized
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Niños "Ricardo Gutierrez"
city: Buenos Aires
country: Argentina
facility: Hospital Interzonal General de Agudos "Dr. Diego Paroissien
city: Santiago
country: Chile
facility: Hospital Clinico Pontificia Universidad Catolica de Chile
Study officials:
affiliation: MedImmune LLC
name: Genevieve Losonsky, MD
role: STUDY_DIRECTOR
References: