Galpin/DA/N2 IIIBenv 
are the results from an experiment in which B ALB/c mice were injected IM three 
times with 1 x 10^ cfu crude HIV-IT (V). These mice were bled 9-15 days post 
injection, and sera were tested for binding to the HIV-1 IIIB envelope protein. 
Specific antibody binding to purified HIV-1 gpl20 was demonstrated by ELISA using 
sera obtained from HIV-IT (V) treated mice, whereas pre-bleed, normal mouse sera 
showed no reactivity. Substantial antibody activity was elicited following the second 
HIV-IT (V) injection. These results demonstrated the ability of direct administration 
of HIV-IT (V) to induce HIV-1 HIBenv-specific antibody. 
3.1.3 Conclusion 
The preceding experiments have demonstrated the feasibility of employing 
HIV-IT (V) to induce HIV-1 env-specific CTL and antibody responses in mice. These 
results established the scientific basis for subsequent studies in non-human primates 
involving the use of HIV-IT (V). The mouse studies illustrate the proof-of-concept 
that direct administration of a retroviral vector can result in the induction of 
HIV-1 env-specific immune responses, including anti-HIV- 1 env crossreactive CTL. 
3.2 NON-HUMAN PRIMATE MODELS 
Preclinical studies employing Rhesus monkeys and baboons were designed to 
evaluate the direct administration of HIV-IT (V) in non-human primate models. The 
primate models were utilized to (1) determine the ability of HIV-IT (V) to induce 
HIV-1 env-specific CTL responses, and (2) to establish an initial dose level, 
administration route, and sample handling procedures. 
Non-human primate studies consisted of two major components: (1) HIV-IT (V) 
administration; and (2) autologous CTL target cell development. An autologous CTL 
target cell line was established for each monkey included in the study. These continuous 
cell lines were initially established by transforming peripheral blood mononuclear cells 
(PBMC) with Herpes papio (HP) or Epstein-Barr (EBV) virus. The established 
transformed cell lines were subsequently transduced with HIV-IT (V), selected in 
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Recombinant DNA Research, Volume 17 
