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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Prophylaxis

Treatments: Other: Placebo; Biological: Motavizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00192504

MI-CP106

Details and patient eligibility

About

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).

Full 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.

Enrollment: 31 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 4 patient groups, including a placebo group

Motavizumab, 3 mg/kg as a single intravenous dose

Experimental group

Description:

Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0

Treatment:

Biological: Motavizumab

Biological: Motavizumab

Biological: Motavizumab

Motavizumab, 15 mg/kg as a single intravenous dose

Experimental group

Description:

Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0

Treatment:

Biological: Motavizumab

Biological: Motavizumab

Biological: Motavizumab

Motavizumab, 30 mg/kg as a single intravenous dose

Experimental group

Description:

Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0

Treatment:

Biological: Motavizumab

Biological: Motavizumab

Biological: Motavizumab

Placebo, as a single intravenous dose

Placebo Comparator group

Description:

Placebo, as a single intravenous dose administered on Day 0

Treatment:

Other: Placebo