nQu 23 '94 15=43 
FROH GENZYnE BIOTHERAP 
TO 913014969839 
PAGE. 012 
Page 7 
NEW ENGLAND MEDICAL CENTER 
CONSENT FORM 
PROJECT TITLE: Adenovirus-mediated gene transfer for Cystic 
Fibrosis: Safety of administration to the lung. 
II. Aerosol Administration 
PI: Henry L. Dorkin, M.D. 
Cl; Joseph Oren, M.D. 
a fever which may last approximately 24 hours. In rare cases 
an infection that will require antibiotics may develop. 
RISKS ASSOCIATED WITH GENE TRANSFER 
The risks associated with gene transfer are largely unknown. 
Possible risks are as follows: 
1. The virus used to deliver the CF gene to your lung might 
cause inflammation and damage to the tissue in the lung. 
These problems might produce cough, chest pain, or bleeding. 
Since the aerosol will deliver the virus to large areas of 
the lung, a significant reaction to the virus, if it were to 
occur, might be associated with increased shortness of 
breath, cough, phlegm production, and fever. Although the 
whole lung will be exposed to the virus, the likelihood of a 
severe reaction will be reduced by using a dose of virus that 
has been previously delivered safely to one segment of the 
lung . 
2. Naturally occurring adenovirus most commonly causes a cold, 
sore throat, and red, sore eyes. In rare cases it has caused 
pneumonia, diarrhea, and inflammation of the bladder. These 
problems are most often caused by different types of 
adenovirus than the adenovirus used in this study. The 
development of one of these problems is possible if the virus 
were to reproduce or if you were to develop a simultaneous 
infection with a natural adenovirus. The use of a virus that 
has been altered to prevent its reproduction, and the 
exclusion of any patients who . have had a recent viral 
infection (e.g. a cold) makes this unlikely. 
3. Your immune system may mount a response to the altered virus 
which might decrease your response to subsequent treatments 
with the virus. The potential significance of such a 
response is unknown at this time. 
4. You may develop an allergic reaction to the virus. This is 
unlikely and has not been seen in the 8 patients treated in 
our nasal studies. 
5. During the 50 years that adenovirus has been studied there 
has been no evidence that it causes cancer. This is because 
adenoviruses, unlike some other viruses, do not introduce new 
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Recombinant DNA Research, Volume 20 
