DESCRIPTION (Provided by Applicant): To date there is no effective HIV vaccine available. Development of a beneficial HIV vaccine has been challenging due to the high mutation rate of the virus, in particular the envelope protein. Many of the 25 or more different HIV vaccines now in clinical trials target the envelope protein in an effort to raise an antibody response to that protein. New insight into effective anti-viral vaccines has focused attention on eliciting cellular immune responses. In addition, mucosal immunity to HIV is desirable for an effective HIV vaccine, since mucosal tissues are the common sites of initial infection. The vaccine being developed by GenStar targets these two issues by the inclusion of the HIV components known to elicit the best cellular immune responses and the ability of adenovirus to produce excellent mucosal immunity. GenStar's proprietary adenoviral vector, Max-Ad, is particularly suited for this approach, since it is a gutless adenovirus with a very large insert capacity. This capacity not only allows the inclusion of multiple HIV components but also the gene for the immunostimulatory cytokine, GM-CSF. In addition, this virus offers efficient transduction of most cells including dendritic cells, excellent high titer large-scale production, and the lack of synthesis of any adenoviral proteins. In the proposed studies we intend to determine the ability of a Max-Ad/HIV vaccine to elicit cellular immune responses to HIV through mucosal delivery. PROPOSED COMMERCIAL APPLICATION: HIV is a world-wide health problem with over 30 million people infected and 15,000 new cases of HIV infections diagnosed each day. Clearly, a prophylactic vaccine for this infectious disease is urgently needed and would produce significant financial and social returns. The potential for effective immunization via a mucosal route such as intranasal spray is particularly attractive in view of the large population at risk and the ease of administration.