Table 3. Risks associated with re-establishing Uganda Schistosoma mansoni life cycle.
Risk | Inherent risk score | Total
inherent risk |
Controls | Residual risk score | Total
risk post control |
||
---|---|---|---|---|---|---|---|
Likelihood | Impact | Likelihood | Impact | ||||
New isolates of
S. mansoni
from the Ugandan population might exhibit variable praziquantel susceptibility, or praziquantel resistance |
Possible | Critical | 15 | 1) Test new isolates for praziquantel
susceptibility in vitro and in an animal model before use in CHI |
Unlikely | Critical | 10 |
New isolates of
S. mansoni
from the Ugandan population might exhibit unexpected virulence |
Possible | Critical | 15 | 1) Test new isolates for relative
virulence in an animal model before use in CHI |
Unlikely | Critical | 10 |
Production processes based
on GMP principles for single- sex infectious cercariae not established in Uganda |
Possible | Critical | 15 | 1) Development of appropriate
animal and snail facilities 2) Training of Ugandan staff 3) Monitoring and review by experienced LUMC collaborators 4) Monitoring and review by Ugandan regulators |
Rare | Critical | 5 |
Likelihood was scored as almost certain/common, 5; likely, 4; possible, 3; unlikely, 2; rare, 1. Impact was scored as critical, 5; major, 4; moderate, 3; minor, 2; insignificant 1.