Table 3.

Detection of FVIII(V) vector in PBMCs




Week
Dose group
Dose, TU/kg
4
13
29
53
1   2.8 × 107  12/12   12/12   10/12   4/8  
2   9.2 × 107  4/4   7/8   11/12   8/8  
3   2.2 × 108  ND   8/8   12/12   ND  
4   4.4 × 108  4/4   12/12   4/4   ND  
5
 
8.8 × 108
 
4/4
 
4/4
 
ND
 
ND
 



Week
Dose group
Dose, TU/kg
4
13
29
53
1   2.8 × 107  12/12   12/12   10/12   4/8  
2   9.2 × 107  4/4   7/8   11/12   8/8  
3   2.2 × 108  ND   8/8   12/12   ND  
4   4.4 × 108  4/4   12/12   4/4   ND  
5
 
8.8 × 108
 
4/4
 
4/4
 
ND
 
ND
 

Numbers represent the number of PCR assays positive over the number of assays performed. When tested, each subject's sample was tested with 4 replicate assays. Thus at week 13 for dose group 1, for example, there were 12 replicate assays, 4 from each of 3 subjects in the group.

PBMC indicates peripheral blood mononuclear cell; ND, assay not performed.

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