Clinical trial NCT00113490: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Motavizumab Administration for a Second Season for RSV Prophylaxis
Keywords: motavizumab, palivizumab, synagis
Rezield, MEDI-524
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-06-09
Enrollment: 136
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

Detailed description: This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.

Eligibility criteria: Inclusion Criteria:

* Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
* The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
* The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
* Written informed consent obtained from the patient's parent(s) or legal guardian

Exclusion Criteria:

* Currently hospitalized
* Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[CPAP\])
* Evidence of infection with hepatitis A, B, or C virus
* Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
* Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
* Acute illness or progressive clinical disorder
* Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
* 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 \[RespiGam(R)\], IVIG), or any investigational agents (except MEDI-524)
* Currently participating in any investigational study

Primary outcomes:
measure: Number of Subjects Exhibiting Anti-motavizumab Antibodies
timeFrame: Day 0 through 120 days post final dose
Secondary outcomes:
measure: Number of Subjects Reporting Adverse Events (AEs)
timeFrame: Day 0 through 30 days post final dose
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Day 0 through 30 days post final dose
measure: Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations
timeFrame: Day 0 through 30 days post final dose
measure: Motavizumab Serum Concentrations at Each Data Collection Visit
timeFrame: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pontificia Universidade Catolica Do Rio Grande
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade
city: Santiago
country: Chile
facility: Hospital Clinico De La Pointificia Universidad
city: Santiago
country: Chile
facility: Hospital Clinico de la Universidad de Chile
city: Santiago
country: Chile
facility: Hospital Dr. Sotero Del Rio
city: Santiago
country: Chile
facility: Hospital San Jose
Study officials:
affiliation: MedImmune LLC
name: M Pamela Griffin, M.D.
role: STUDY_DIRECTOR
References:
citation: Abarca K, Jung E, Fernandez P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03.