Table 2.

Vector Shedding in Clinical Trials of Liver-Directed Gene Therapy

Serotype	SPK-9001 (Serotype Unknown) 5 × 1011 gc/kg25	scAAV2/8-LP1-hFIXco 2 × 1012 gc/kg22	AAV5-hFIXWT (AMT-060) 5 × 1012 gc/kg23	AAV5-hFIXWT (AMT-060) 2 × 1013 gc/kg23	AAV5-hFVIII-SQ (Valoctocogene Roxaparvovec) 6 × 1013 gc/kg24
	SPK-100	AAV2/8	AAV5	AAV5	AAV5
Period of Vector Shedding, Weeks (Maximum or Range)
Nasal secretions	not reported	not reported	18	12	not reported
Saliva	4–6	2	20	16	40–52
Feces	not reported	2	16	20	present to final assessment (week 52)
Urine	2–8	not reported	11	22	6–28
Semen	4–12	2	48	22	36–56
Whole blood	22–42 (PBMCs)	2 (plasma)	present to final assessment (week 52)	present to final assessment (week 26)	present to final assessment (week 52)

Gc, genome copies; PBMCs, peripheral-blood mononuclear cells.