Galpin/DA/N2 IIIBenv 
samples obtained following each injection of HIV-IT (V) showed an HIV-1 gpl20 
specific antibody response as compared to pre-bleed serum. Therefore, the injection of 
HIV-IT (V) appears to elicit gp 120-specific antibodies in a baboon. 
3.2.3 Toxicological Assessment 
Toxicology studies were performed in Rhesus monkeys given direct 
administration of a 5 x 10 7 cfu HIV-IT (V) retroviral vector possessing the same 
provector as DA/N2 IIIBenv. 2C3 but derived from a different canine PCL. Monkeys 
were evaluated clinically and histologically during and following 4 IM injections of 
HIV-IT (V). Two groups (6/group) of male and female monkeys were given 
HIV-IT (V) or diluent control. None of the animals exhibited clinical abnormalities 
during the 1 year study. In addition, following necropsy and histological preparation 
of various tissues no pathological lesions were detected. Therefore, the 
retroviral-vector delivered N2 IIIBenv provector construct did not induce any 
significant toxicological effects in Rhesus monkeys. 
3.2.4 Conclusion 
In conclusion, the preceding studies demonstrated the ability of HIV-IT (V) to 
induce HIV-1 env-specific CTL and antibody responses in non-human primate models. 
These studies have also demonstrated lack of acute or chronic toxicity in Rhesus 
monkeys. 
3.3 VECTOR LOCALIZATION 
Experiments have been initiated to analyze localization of HIV-IT (V) after IM 
administration. Early studies have focused on analysis of the injection site (muscle), the 
planned site for human trials, with the aim of demonstrating the in vivo appearance of 
HIV-IT (V) DNA early after vector administration and the subsequent clearance of vector 
transduced cells over time. 
To examine the appearance of HIV-IT (V) DNA at the injection site, eight- week old 
mice (12 males, 4 females) were injected IM one time with 0.1 ml (1 x lO^cfu) of 
Recombinant DNA Research, Volume 17 
