Intranasal Palivizumab Fails to Prevent RSV Infection in Preterm Babies
A recent double-blind, randomized placebo-controlled trial found that daily intranasal palivizumab, a mucosal monoclonal antibody (mAb) did not prevent Respiratory Syncytial Virus (RSV) infection in late preterm infants. The findings were published in eClinicalMedicine of Lancet.
A total of 268 infants were enrolled from January 14, 2019 to January 28, 2021, with half receiving intranasal palivizumab and the other half a placebo once daily during the RSV season. The trial was halted for futility following a planned interim analysis.
Adverse events were observed to be similar in both groups, with 22 (16.4%) in the palivizumab arm and 26 (19.4%) in the placebo arm. But, 168 infants were excluded from efficacy analyses due to the absence of RSV circulation during the SARS-CoV-2 pandemic.
The primary outcome showed no significant difference between groups (38.3% in the palivizumab arm versus 23.4% in the placebo arm) in regard to RSV infection. Also, the findings underscore the importance of timely interim analyses in mucosal mAb clinical development.
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