The matter of the vector AAV8 has always been listed in the trial protocol as an exclusion criteria.
https://clinicaltrials.gov/ct2/show/NCT01899092?term=TT-034&rank=1
Exclusion Criteria:
- Body mass index < 18.5 or > 30
- Female subjects of childbearing potential (including females with tubal ligation) or women who are pregnant or nursing
- Male subjects who are unwilling to provide the required semen samples
- Presence of nAb levels to AAV8 that abrogate AAV8 transduction
I would have thought that the clinical trial has merits going ahead because immunity would not have been such an issue, no?
The matter of the vector AAV8 has always been listed in the...
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