CLINICAL AND IMMUNOLOGICAL RESPONSES TO HUMAN-IMMUNODEFICIENCY-VIRUS (HIV) TYPE 1(SF2) GP120 SUBUNIT VACCINE COMBINED WITH MF59 ADJUVANT WITH OR WITHOUT MURAMYL TRIPEPTIDE DIPALMITOYL PHOSPHATIDYLETHANOLAMINE IN NON-HIV-INFECTED HUMAN VOLUNTEERS

A phase 1 study of 42 non-human immunodeficiency virus type 1 (HIV)-in fected volunteers was initiated to determine the safety and immunogeni city of an HIV subunit vaccine consisting of recombinant envelope gp12 0 derived from HIVSF2 (rgp120(SF2)) combined with a novel adjuvant, MF 59, with or without the immunomodulator muramyl tripeptide dipalmitoyl phosphatidylethanolamine (MTP-PE). All injections contained adjuvant MF59, and subjects were grouped according to MTP-PE dose. Injections w ere given on days 0, 30, 180, and 365. The vaccine was well tolerated with limited local and systemic reactions. These immunizations induced rgp120(SF2)-specific binding antibodies that persisted greater than o r equal to 24 weeks. After three immunizations, all subjects receiving the antigen developed neutralizing antibodies to HIVSF2, and serum fr om 67% of these subjects also cross-neutralized HIVMN. ELISA-reactive antibodies to the HIVSF2 V3 region and strong lymphoproliferative resp onses to HIVSF2 envelope proteins were detected in all rgp120(SF2)-imm unized subjects.