to minimize the chance of complementation by wild-type adenovirus as described in the human 
protocols. 
4.5. Risk of Vertical or Germline Transmission: Could the AvlCF2 CFTR cDNA be 
transferred to the germ line? As the integration frequency of wild type adenovirus is very low 
(Karlsson et.al., 1985, 1986) and that of AvlCF2 even lower due to the absence of replication 
and lower cellular genomic copy number, germline transmission is unlikely. Further, since most 
males with cystic fibrosis are sterile (Boat et.al., 1989), at least for males, this risk is even less. 
Nonetheless, to minimize the risk of germline transmission, males will be required to use a 
sheath with a spermicidal jelly while participating in the study protocol. Females with cystic 
fibrosis have reduced fertility, which is approximately 50% normal. To insure that germ line 
transmission of the transferred gene does not occur in female subjects, the female cystic fibrosis 
patients being considered for the protocol will need to have documented sterility by tubal 
ligation, absence of ovaries, or absence of the uterus, or to be using an effective method of birth 
control which will be maintained during the study. 
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