of AvlCF2. PCR will also be performed for wild adenovirus, and blood will be obtained for 
adenovirus serology, CBC and differential, PT, PTT, serum chemistry, and a urinalysis. 
Day 14: History and physical examination will be repeated. Oxygen saturation and pulmonary 
function tests will be repeated. Adenovirus and serum for antibody will be collected. Blood 
will be taken for CBC and differential, PT, PTT, and serum chemistry. A urinalysis will be 
performed. 
If the recombinant virus is no longer present as free viral particles in secretions, the culture 
on 293 cells will be negative. If patients have cleared the recombinant virus, they will be 
discharged at this point. If the virus has not been cleared, the admission will be continued and 
cultures will be checked every 3 days until the recombinant virus has been eliminated. 
The criteria for discharge will be a negative culture for the recombinant adenovirus on 293 
cells and a negative PCR for wild adenovirus. The cell line 293 is a human renal cell line that 
contains 11% of the left end of adenovirus 5, and it complements the replication deficient 
adenovirus construct, permitting its growth in culture. This system will culture free viral 
particles present in secretions but not intracellular viral particles (AvlCF2). 
Following discharge, patients will be asked to remain at home and to avoid contact with 
sick individuals and young children. They will also be asked to avoid crowded places such as 
movie theaters and shopping malls. In this way, we will decrease the risk of a wild adenovirus 
infection that could, in theory, complement the replication deficient virus and produce an 
infectious agent. 
Day 21: History and physical examination will be repeated. Oxygen saturation and pulmonary 
function tests will be repeated. Blood will be drawn for adenovirus serology, CBC and 
differential, PT and PTT, serum chemistry. Urinalysis will be obtained. 
Day 28: Patients will be readmitted to the clinical research center for studies. History and 
physical will be obtained. Chest x-ray will be repeated. Oxygen saturation and pulmonary 
function tests will be performed. Patients will be sedated and nasal potential difference, nasal 
brushing and biopsy, tracheal potential difference, bronchoscopy for BAL, brushings and 
biopsy will be performed as previously. Pharyngeal swabs and stool will be obtained for 
culture, and PCR will be performed for wild adenovirus infection. Blood will be drawn for 
adenovirus serology, CBC and differential, PT and PTT, and serum chemistry. Urinalysis and 
sputum culture will be obtained. 
Days 35, 42, 49: Patients will be seen at weekly intervals to check on their progress. History 
and physical will be obtained. They will have oxygen saturation and pulmonary function tests 
performed. Adenovirus cultures will be repeated on pharyngeal cultures and stool, PCR for 
wild adenovirus will be performed. Blood will be obtained for adenovirus serology, CBC and 
differential, PT and PTT, serum chemistry. Urinalysis will be obtained. 
Day 55: Patients will be readmitted into isolation in the clinical research center to prepare for 
a repeat treatment to the same lobe with the AvlCF2 construct. On admission, they will have 
a history and physical. Chest x-ray, scans, oxygen saturation, and PFTs will be repeated. 
Adenovirus culture and PCR will be repeated. Blood will be drawn for adenovirus serology, 
CBC and differential, PT and PTT, and serum chemistry. Urinalysis will be repeated. Sputum 
culture will be obtained. 
Recombinant DNA Research, Volume 17 
[397] 
