Revised 8-26-94 
Exclusion requirements: 
If you do not meet any of the inclusion requirements above, you will be unable 
to participate in the protocol. 
If you have an active respiratory tract infection (beyond the baseline infec- 
tion that is present in all individuals with CF) in the 1 week prior to 
beginning the protocol, you will not be able to participate. Similarly, if you 
have an active respiratory tract infection in the week prior to parts 2 or 3 
of the protocol, you will not be allowed to enter these parts. Requirements 
for diagnosis of infection are rhinitis, pharyngitis, conjunctivitis, 
bronchitis, evidence of fever or changes in sputum requiring antibiotics or a 
change in antibiotics. 
If there is evidence of cardiac, renal, central nervous system, major 
psychiatric disorder, musculoskeletal disease or immunodeficiency disease, 
(including evidence of human immunodeficiency virus infection, HIV), you will 
be unable to participate in the protocol. The absence of HIV infection is 
critical because it might be dangerous to administer Ad^vCFTR-lO to such in- 
dividuals given that severe or lethal adenoviral infections have been reported 
in individuals with HIV infection. 
If you are receiving corticosteroids or other immunosuppressive medicines 
which decrease the body's capacity to respond to infections, you will not be 
able to participate. 
Protocol : 
The clinical study will include 26 individuals with cystic fibrosis. The study 
has three parts, referred to as A, B and C. So that you may have an overview 
of the entire study, all parts will be described to you, although no one in- 
dividual will participate in all parts. You are to be enrolled in Part 
(The physicians conducting the study will fill in the blanks prior to you 
signing this consent form. Individuals enrolled in Part A are automatically 
enrolled in Part C) . 
Part A starts with a baseline period that has an initial evaluation followed 
by a series of studies to determine your eligibility for the study, and to 
establish "baseline" values to which the safety and efficacy (potential good 
results) of the administration of the AdcvCFTR.lO vector can be compared. The 
baseline period will require 2-3 days in the hospital and 1-2 visits to the 
outpatient clinic to be completed. Details of the baseline period can be found 
in section 6.1 of the protocol, and a schedule of all tests in the baseline 
period can be found in the Appendix A5 . 1 . 
If, after completing the baseline period, you wish to continue and still meet 
all the inclusion and exclusion requirements, you will next move to the 
vehicle control period. You must enter the vehicle control period within 3 
months following completion of the baseline period. If the time since ending 
the baseline period is greater than this period, there will be a reassessment 
of the safety and efficacy measurements (see protocol, section 6.2 and ap- 
pendix A5.2). In the vehicle control period you will again undergo the same 
type of tests as in the baseline period but with one difference. You will have 
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