rgp120/HIV-1 SF-2(Genentech)

To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months.
Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months.
Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections.
One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine.