A dose-ranging study of a prototype synthetic HIV-1MN V3 branched peptide vaccine. The National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group.
A phase I double-blind trial was done to examine the safety and immunogenicity of a prototype synthetic human immunodeficiency virus type 1 MN strain (HIV-1MN) third variable region domain (V3) branched peptide vaccine in HIV-1-uninfected healthy adult volunteers. Subjects were randomly assigned to receive 20, 100, or 500 micrograms of vaccine or alum adjuvant control on days 0, 28, and 168. The vaccine was well-tolerated and appeared safe. Induction of binding antibody to V3 MN branched peptide was vaccine dose-related and was detectable in 9 of 10 subjects in the highest-vaccine-dose group. HIV-1MN-neutralizing antibody was detected after the third 500-micrograms dose in 8 of 10 subjects at the 90% neutralization end point. V3 MN peptide stimulated lymphocyte proliferation in 15 (75%) of 20 subjects after vaccination. In conclusion, this prototype vaccine was safe and it induced humoral and cell-mediated immune responses.
Gorse
G J
GJ
Division of Infectious Diseases and Immunology, Saint Louis University School of Medicine, Missouri 63110-0250, USA.
Keefer
M C
MC
Belshe
R B
RB
Matthews
T J
TJ
Forrest
B D
BD
Hsieh
R H
RH
Koff
W C
WC
Hanson
C V
CV
Dolin
R
R
Weinhold
K J
KJ
Frey
S E
SE
Ketter
N
N
Fast
P E
PE
D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D000328:Adult; D000595:Amino Acid Sequence; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015483:HIV Antibodies / Q000032:analysis*; D015699:HIV Envelope Protein gp120 / Q000737:chemistry / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D009500:Neutralization Tests; D010446:Peptide Fragments / Q000737:chemistry / Q000276:immunology*
D016915:AIDS Vaccines; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120; C059762:HIV envelope protein gp120 (305-321); D010446:Peptide Fragments