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randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus
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randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus
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randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus
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Journal Article
randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus
2010
Overview
RNA interference (RNAi) is a natural mechanism regulating protein expression that is mediated by small interfering RNAs (siRNA). Harnessing RNAi has potential to treat human disease; however, clinical evidence for the effectiveness of this therapeutic approach is lacking. ALN-RSV01 is an siRNA directed against the mRNA of the respiratory syncytial virus (RSV) nucleocapsid (N) protein and has substantial antiviral activity in a murine model of RSV infection. We tested the antiviral activity of ALN-RSV01 in adults experimentally infected with wild-type RSV. Eighty-eight healthy subjects were enrolled into a randomized, double-blind, placebo-controlled trial. A nasal spray of ALN-RSV01 or saline placebo was administered daily for 2 days before and for 3 days after RSV inoculation. RSV was measured serially in nasal washes using several different viral assays. Intranasal ALN-RSV01 was well tolerated, exhibiting a safety profile similar to saline placebo. The proportion of culture-defined RSV infections was 71.4 and 44.2% in placebo and ALN-RSV01 recipients, respectively (P = 0.009), representing a 38% decrease in the number of infected and a 95% increase in the number of uninfected subjects. The acquisition of infection over time was significantly lower in ALN-RSV01 recipients (P = 0.007 and P = 0.03, viral culture and PCR, respectively). Multiple logistic regression analysis showed that the ALN-RSV01 antiviral effect was independent of other factors, including preexisting RSV antibody and intranasal proinflammatory cytokine concentrations. ALN-RSV01 has significant antiviral activity against human RSV infection, thus establishing a unique proof-of-concept for an RNAi therapeutic in humans and providing the basis for further evaluation in naturally infected children and adults.
Publisher
National Academy of Sciences,National Acad Sciences
Subject
/ Adult
/ adults
/ Antiviral Agents - metabolism
/ children
/ Human respiratory syncytial virus
/ Humans
/ nose
/ Placebos
/ Proteins
/ Respiratory Syncytial Virus Infections - genetics
/ Respiratory Syncytial Virus Infections - therapy
/ Respiratory Syncytial Virus Infections - virology
/ Respiratory Syncytial Virus, Human - genetics
/ Respiratory syncytial viruses
/ RNA
/ RNA, Small Interfering - genetics
/ Symptoms
/ Viruses
