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NEW ENGLAND MEDICAL CENTER 
CONSENT FORM 
PROJECT TITLE: Adenovirus -media t ed 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. 
If you agree to participate in the study, 3 weeks prior to the 
administration of Ad2/CFTR-2 you will come to the hospital for an 
extensive screening evaluation. You should expect to spend three 
to four hours at this visit. At that time your physician will 
review your medical history, perform a complete physical 
examination, and obtain a full set of pulmonary function tests, 
which you have previously performed as part of your routine care. 
Blood will be drawn from your vein (a total of approximately 60 
cc or 1/4 cup) for multiple studies. These studies will include 
a test to determine whether or not you have immunity to 
adenovirus, so that we will know if you have ever been exposed to 
the common, naturally occurring adenovirus. The presence of 
antibody to the adenovirus provides an additional measure of 
safety should you develop a reaction to the adenovirus. We will 
also determine the specific gene for cystic fibrosis which you 
carry in your chromosomes from a blood sample. By collecting 
specimens of nasal secretions, stool, and urine, we will 
determine whether you currently have a natural type of adenovirus 
in your body, which could make administration of Ad2/CFTR-2 
unsafe. If you are a female of child bearing potential, a 
pregnancy test will also be done. 
One week prior to application of Ad2/CFTR-2, a physical 
examination will be performed, and blood tests, cultures, a 
limited set of pulmonary function tests, and a chest x-ray will 
be obtained. 
Hospital Admission/Administration of Ad2/CFTR-2 
If you are eligible for participation in the study you will be 
admitted to the hospital for 4 days. On the first day, a 
physical examination will be performed, and blood tests, 
cultures, pulmonary function tests, and a limited chest CT scan 
will be obtained. Later that day, Ad2/CFTR-2 will be 
administered to you in an aerosol that you will breathe into your 
lungs. Since the risks of delivering Ad2/CFTR-2 by aerosol are 
currently unknown, the aerosol will be delivered to you inside a 
canopy to prevent spread of the virus. We will also ask that you 
wear a gown, gloves, and protective eye wear while receiving the 
aerosol . 
After application of Ad2/CFTR-2 you will be required to be in 
respiratory isolation for 24 hours from the time of 
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