Abstract
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.
Publication types
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Clinical Trial
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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Acetylmuramyl-Alanyl-Isoglutamine / adverse effects
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Acetylmuramyl-Alanyl-Isoglutamine / analogs & derivatives
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Acetylmuramyl-Alanyl-Isoglutamine / immunology
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Adjuvants, Immunologic / adverse effects
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Adult
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Antiviral Agents / adverse effects
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Antiviral Agents / immunology
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Blotting, Western
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Drug Evaluation
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Drug Tolerance
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Enzyme-Linked Immunosorbent Assay
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HIV Antibodies / biosynthesis
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HIV Envelope Protein gp120 / immunology
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HIV-1 / immunology*
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Humans
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Immunoblotting
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Leukocytes, Mononuclear / immunology
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Lymphocyte Activation
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Male
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Middle Aged
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Phosphatidylethanolamines / adverse effects
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Phosphatidylethanolamines / immunology
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T-Lymphocytes / immunology
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Vaccines, Synthetic / adverse effects
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Vaccines, Synthetic / immunology
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Viral Vaccines / adverse effects
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Viral Vaccines / immunology*
Substances
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Adjuvants, Immunologic
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Antiviral Agents
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HIV Antibodies
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HIV Envelope Protein gp120
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Phosphatidylethanolamines
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Vaccines, Synthetic
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Viral Vaccines
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mifamurtide
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Acetylmuramyl-Alanyl-Isoglutamine