Virus shedding after administration of rAAV in rhesus macaques.

A PCR-based assay was used to detect vector sequences in plasma (P), urine (U), and saliva (S) collected from monkeys 1 to 4 on the stipulated days after liver-targeted delivery of rAAV CAGG-FIX. The PCR primers were chosen specifically to amplify a 512-bp hFIX transgene–specific product (arrow labeled FIX). Standards consisting of serial dilutions of rAAV CAGG-FIX in rhesus plasma were used to define the sensitivity of the assay. Twenty percent of the samples were electrophoresed on a 1.5% agarose gel. Negative samples were spiked with vector plasmid and subjected to PCR to ensure that the sample did not inhibit the PCR reaction.