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29/10/14
17:00
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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?
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