Clinical and immunologic responses to human immunodeficiency virus (HIV) type 1SF2 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)-infected volunteers was initiated to determine the safety and immunogenicity of an HIV subunit vaccine consisting of recombinant envelope gp120 derived from HIVSF2 (rgp120SF2) combined with a novel adjuvant, MF59, 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 were given on days 0, 30, 180, and 365. The vaccine was well tolerated with limited local and systemic reactions. These immunizations induced rgp120SF2-specific binding antibodies that persisted > or = 24 weeks. After three immunizations, all subjects receiving the antigen developed neutralizing antibodies to HIVSF2, and serum from 67% of these subjects also cross-neutralized HIVMN. ELISA-reactive antibodies to the HIVSF2 V3 region and strong lymphoproliferative responses to HIVSF2 envelope proteins were detected in all rgp120SF2-immunized subjects.
Kahn
J O
JO
AIDS Program, San Francisco General Hospital, CA 94110.
Sinangil
F
F
Baenziger
J
J
Murcar
N
N
Wynne
D
D
Coleman
R L
RL
Steimer
K S
KS
Dekker
C L
CL
Chernoff
D
D
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology*; D000119:Acetylmuramyl-Alanyl-Isoglutamine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D015483:HIV Antibodies / Q000097:blood; D015699:HIV Envelope Protein gp120 / Q000276:immunology*; D006801:Humans; D007114:Immunization; D008297:Male; D008875:Middle Aged; D010714:Phosphatidylethanolamines / Q000008:administration & dosage*; D011136:Polysorbates / Q000008:administration & dosage*; D013185:Squalene / Q000008:administration & dosage*; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology*
D016915:AIDS Vaccines; D000276:Adjuvants, Immunologic; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120; C089950:MF59 oil emulsion; D010714:Phosphatidylethanolamines; D011136:Polysorbates; D014614:Vaccines, Synthetic; C037144:mifamurtide; D000119:Acetylmuramyl-Alanyl-Isoglutamine; D013185:Squalene