M.J. Welsh and A.E. Smith, RAC Application 
Stool culture. Stools were collected every week and cultured for virus; all were negative. 
Adenovirus antibody titers. No increase in antibody to adenovirus or adenovirus 2 was 
detected at any of the time points. 
Conclusion. 
The results of this experiment are important in several respects. Despite being housed in 
close proximity to two monk eys t reated with Ad2/6Gal-l bronchial instillation and 3 
monkeys treated with Ad2/CFTR-1 virus, the sentinel monkey developed no increase in 
antibody titers to the virus. Moreover, no live virus was isolated at any point from the lung 
or nose or from stool samples of the sentinel monkey. The fact that the sentinel monkey 
had eosinophilia on bronchial brushings and bronchoalveolar lavage, suggests that it was 
not due to the recombinant virus. 
B.3. Clinical procedures, including patient monitoring . 
Describe the treatment that will be administered to patients and the diagnostic 
methods that will be used to monitor the success or failure of the treatment. If 
previous clinical studies using similar methods have been performed by yourself or 
others, indicate their relevance to the proposed study. 
1. Study design. 
This is a nonrandomized, nonblinded administration of recombinant Ad2/CFTR-1 virus to a 
defined and limited area of respiratory nasal epithelium. 
2. Pretreatment evaluation. 
To insure clinical stability, participants will enter the study at least 6 weeks before 
administration of virus. They will then be followed as outpatients at 3 to 4 week intervals 
until admission for application of the recombinant virus. Participants will receive the 
evaluation described below at the time of entry into the study and then at the time of 
admission to the hospital. They may also receive any of the following tests between 
enrollment and administration of the recombinant virus at the discretion of the 
investigators, if there is a significant change in clinical status. 
a. Complete history and chart review and assessment by NIH scoring system. 
b. Physical examination, including nasal endoscopy. 
c. CF genotyping. 
d. Blood samples for: complete blood count (including platelets and differential WBC), 
erythrocyte sedimentation rate, electrolytes (including Na, K, Cl, and HCO3), and general 
chemistries (including total protein, albumin, Ca, PO4, glucose, uric acid, alkaline 
phosphatase, total bilirubin, AST, LDH, BUN, Cr, and amylase). 
e. Adenovirus antibody titers. 
f. Cultures. Culture of sputum, nasal swab, stool, and urine for wild-type adenovirus. 
Bacterial culture of sputum and nasal swab. 
g. Nasal swab and nasal brushing for cell count and cell morphology and PCR for El DNA 
sequences. 
Recombinant DNA Research, Volume 16 
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