Safety and immunogenicity of a genetically engineered human immunodeficiency virus vaccine.
A phase 1 trial of a candidate human immunodeficiency virus type 1 (HIV-1) vaccine was done in 25 healthy seronegative subjects. The antigen, env2-3 (SF2), was a nonglycosylated polypeptide representing the gp120 region of the env gene of the HIV-1(SF2) isolate. It was produced in genetically engineered yeast as a denatured molecule incapable of binding CD4. A synthetic lipophilic muramyl tripeptide (MTP-PE) was used as an adjuvant. Ten subjects received adjuvant alone and 15 received 50- or 250-micrograms doses of env2-3 (SF2) administered intramuscularly in two immunization regimens. In general, adjuvant and vaccine were well tolerated. Antibody responses to both the homologous antigen, env2-3 (SF2), and antigens from other highly divergent HIV isolates were elicited in the majority of vaccine recipients. However, antibody titers were low, without neutralizing activity. In 9 of 11 subjects who received the complete vaccine immunization series, a significant specific T lymphocyte response was observed.
Wintsch
J
J
Department of Medicine, University Hospital, Geneva, Switzerland.
Chaignat
C L
CL
Braun
D G
DG
Jeannet
M
M
Stalder
H
H
Abrignani
S
S
Montagna
D
D
Clavijo
F
F
Moret
P
P
Dayer
J M
JM
D000119:Acetylmuramyl-Alanyl-Isoglutamine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000276:immunology; D000276:Adjuvants, Immunologic / Q000009:adverse effects; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000276:immunology; D015153:Blotting, Western; D004341:Drug Evaluation; D004361:Drug Tolerance; D004797:Enzyme-Linked Immunosorbent Assay; D015483:HIV Antibodies / Q000096:biosynthesis; D015699:HIV Envelope Protein gp120 / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D015151:Immunoblotting; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D010714:Phosphatidylethanolamines / Q000009:adverse effects / Q000276:immunology; D013601:T-Lymphocytes / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
D000276:Adjuvants, Immunologic; D000998:Antiviral Agents; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120; D010714:Phosphatidylethanolamines; D014614:Vaccines, Synthetic; D014765:Viral Vaccines; C037144:mifamurtide; D000119:Acetylmuramyl-Alanyl-Isoglutamine