Revised 8-26-94 
Part B of the protocol starts with a baseline period and is followed by a ve- 
hicle control period that are identical to that for part A described above 
(see sections 7.1, 7.2 and appendices A5 . 1 , A5.2). 
If you wish to continue the protocol and still meet all of the inclusion req- 
uirements, you may move on to the Ad^vCFTR-lO treatment period. Details of the 
AdcvCFTR.10 treatment period can be found in section 7.3 and appendix A5 . 5 . On 
day 1 of the AdcvCFTR.lO treatment period, you will receive AdcvCFTR.10 in a 
fashion identical to that described for part A. When the tests following the 
AdcvCFTR.10 administration are completed, you will then receive the same dose 
of AcfjvCFTR.10 at fixed intervals for a total of up to 6 six doses. Following 
each dosing, you will have a series of tests to evaluate safety and function 
of AdcvCFTR.10 in your airways. All of these tests are detailed in appendix 
A5 . 5 . The interval between doses will be based on the results from Part A from 
other individuals (which will take place before part B) . You will receive the 
AdcvCFTR.lO vector on days , , , , and . The dose at 
each time will be plaque forming units (if you are participating in 
part B, these blanks will be filled in by the physicians conducting the study 
before you sign this consent form). 
The natural history of cystic fibrosis is associated with exacerbations (wors- 
ening) of the disease, particularly respiratory problems. It is thus possible 
that among the individuals in this protocol, exacerbations of respiratory or 
non- respiratory problems may occur. Should exacerbations of disease in any 
part of the body occur during any part of the protocol, you will be treated. 
During the period of illness, assessment of safety and effectiveness of the 
AdcvCFTR-lO administration will continue as long as such assessment does not 
interfere with your clinical care and welfare. It is possible that you will 
not be able to continue with the protocol because of intercurrent illness. 
In the event that bad side effects are attributable to administration of 
AdcvCFTR.lO or study procedures occur during the protocol, you will be treated 
by conventional clinical therapy. Assessment of safety and effectiveness of 
the AdcvCFTR.10 administration will continue as long as such assessment does 
not interfere with your clinical care and welfare. It is possible that you 
will not be able to continue with the protocol because of adverse effects, 
although all possibilities will be explored to prevent removal from the study, 
as long as your welfare is ensured. 
The tests in the baseline period include blood tests, urine tests, electrocar- 
diogram, chest X-rays, computed tomography scan of the chest (a specialized 
type of chest X-ray), lung function tests, collection of sputum, bronchoscopy 
(to evaluate the air passages, to recover some of the cells and tissues, and 
the fluid lining the air passages) , and measurement of the electrical poten- 
tial difference between the nose and/or airways and the skin. The tests in the 
vehicle control period and the AdcvCFTR.lO treatment period are similar, ex- 
cept a few tests (HIV blood test, computed tomography scan of the chest) do 
not have to be repeated. For timing and detail of these tests, see sections 
6.8 of the protocol, and the "time-line" charts attached to the protocol. The 
following discussion relates to details of the risks of these tests. All are 
routine tests in clinical medicine. Each is an accepted, safe medical test. 
Like most medical tests however, there are some associated discomforts and 
risks . 
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