Report Summary

Toxicity and Vector Distribution Study in Rats Following A Single Injection into the Submandibular Duct. Test article Adenovirus/AdCMVH3

Study Summary

Overall Study Design 
The purpose of this study was to assess the toxicity and biodistribution of an adenovirus vector AdCMVH3 following a 
single injection into the submandibular duct of rats using the polymerase chain reaction PCR technique 
Groups of 15 male and 15 female Wistar rats were administered a single 50 microliter injection of 106 3 x 107 or 109 
pfu of AdCMVH3 via the right submandibular duct An additional group of 15 mles and 15 females were administered a 
single 50 microliter injection of AdCMVH vehicle virus dilution buffer via the submandibular duct and housed in a different 
room from treated animals Animals were observed twice daily for moribundity and mortality and once daily for clinical signs 
of toxicity A more thorough hands-on examination was performed several times after dosing on Day 1 and at weekly 
intervals thereafter Body weights were measured for all animals on Day 1 and at weekly intervals Animals scheduled for 
sacrifice were also weighed the day prior to sacrifice Food consumption was measured on Days 1 7 for animals sacrificed 
on Day 8 and 14 except for those animals sacrificed on Day 2 
Prior to blood collection on the days of sacrifice Days 2 8 and 15 the animals were anesthetized and saliva was collected 
for Histatin 3 and PCR analysis determinations Samples that were postive for the presence of adenovirus sequences by 
PCR were tested for the presence of replication competent adenovirus by culture with susceptible indicator cells 
Surviving animals were bled from the retro orbital sinus for clinical pathology and PCR analyses An extensive and 
specialized PCR necropsy was performed for scheduled sacrifices and collected tissues were snap frozen in liquid nitrogen 
for PCR analysis or fixed in 10 formalin for histopathological evaluation Any gross lesions were noted 
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