Palivizumab for Reduction of Respiratory Syncytial Virus Infections
Molly Miloslavsky
Chadi M. El Saleeby
Palivizumab, a Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus Infection in High-Risk Infants. The IMpact-RSV Study Group
Pediatrics. 1998;102(3 Pt 1):531–537
Background
In the US, respiratory syncytial virus (RSV) is the leading cause of respiratory illness in infants and children under age 2. Risk factors for severe disease include prematurity, chronic lung disease (CLD), and hemodynamically significant cardiac lesions. Prior to this study, RSV IV immunoglobulin (RSV-IVIG) was shown to be effective RSV prophylaxis in high-risk pediatric patients.1 However, long infusion time precluded widespread use. Palivizumab, a humanized monoclonal antibody, was an attractive alternative as it had potent anti-RSV activity in vitro and could be given intramuscularly (IM).
Objectives
To determine the safety and efficacy of IM palivizumab as RSV prophylaxis in high-risk infants.
Methods
Double-blind, randomized, placebo-controlled trial in 139 centers in the US, Canada, and the United Kingdom from 1996 to 1997.
Patients
1,502 children age ≤6 months with history of prematurity ≤35 weeks’ gestation or age ≤24 months with a history of bronchopulmonary dysplasia (BPD) requiring supplemental oxygen, corticosteroids, bronchodilators, or diuretics in the past 6 months. Select exclusion criteria: significant congenital heart disease, recent or active RSV infection.
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