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Motavizumab was safe, effective in the reduction of RSV infection in children
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A respiratory syncytial virus–specific humanized monoclonal antibody — motavizumab — reduced cultivatable disease in the upper respiratory tract of children, according to the findings of a phase-1 trial.
Researchers randomly assigned children aged younger than 2 years from the United States and Chile to a single IV infusion of motavizumab 3 mg/kg, 15 mg/kg or 30 mg/kg (n=16) or placebo (n=15).
One day post-treatment, 73% of children in the motavizumab group tested negative for RSV in nasal secretion cultures compared with 27% of children in the placebo group (P<.05). The RSV load was 1.3 log10 PFU/mL in the motavizumab groups combined vs. 3.0 log10 PFU/mL in the placebo group (P=.01).
By day seven, 57% of children in the motavizumab group had RSV detectable through nasal secretions, whereas 93% of children in the placebo group still had disease (P<.05). On day one, 87% of the motavizumab group vs. 33% of the placebo group were negative for RSV based on frozen nasal secretions (P<.01).
On day two, mean trough serum concentrations of motavizumab were 62 mcg/mL in the 3 mg/kg group, 171 mcg/mL in the 15 mg/kg group and 333 mcg/mL in the 30 mg/kg group. On day 30, concentrations were 17 mcg/mL in the 3 mg/kg group, 59 mcg/mL in the 15 mg/kg group and 80 mcg/mL in the 30 mg/kg group.
Lagos R. Pediatr Infect Dis J. 2009;28:835-837.