NOU 23 ’94 15=49 
FROM GENZYME BIOTHERRP 
TO 913014969639 
PAGE. 025 
SHS Approval Scamp Pacient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page 8 
Title of Project: Adenovirus-Mediated Gene Transfer for Cvst-ir 
Fibrosis: Safety of Single Lcbar Administration in the Luna 
Principal Investigator: Allen Laoev. M.D. 
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 
genes into the chromosome. However, this also means that any 
correction of the genetic defect in you lung will only be 
temporary . 
Recombinant DNA Research, Volume 20 
[585] 
