Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative.

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative.

AIDS. 1998 Jul 30;12(11):1291-300. Unique Identifier : AIDSLINE MED/98372113
Bartlett JA; Wasserman SS; Hicks CB; Dodge RT; Weinhold KJ; Tacket CO; Ketter N; Wittek AE; Palker TJ; Haynes BF; Department of Medicine, Duke University Medical Center, Durham,; North Carolina 27710, USA.

Abstract: OBJECTIVE: To evaluate the safety and immunogenicity of a polyvalent (PV) HIV envelope synthetic peptide immunogen, C4-V3. The immunogen comprised four peptides containing T-helper epitopes from the fourth constant region (C4) of gp120 of HIV-1MN, and T-helper, cytotoxic T-lymphocyte HLA-B7-restricted, and B-cell neutralizing epitopes from the gp120 third variable region (V3) of four clade B HIV-1 isolates, HIV-1MN, HIV-1RF, HIV-1EV91, and HIV-1Can0A. DESIGN: A pilot, Phase I controlled trial [Division of AIDS Treatment Research Initiative (DATRI) 010] conducted at a single center. METHODS: Ten HIV-infected, HLA-B7-positive patients with CD4 cells > 500 x 10(6)/l were enrolled. Eight patients received the C4-V3 PV immunogen emulsified in incomplete Freund's adjuvant in five intramuscular injections over 24 weeks, and two controls received incomplete Freund's adjuvant alone. All subjects were followed for 52 weeks. RESULTS: Four out of eight C4-V3 PV recipients generated at least fourfold rise in serum antibody titers to at least three immunogen peptides in contrast to none of the control subjects. Four out of eight C4-V3 PV recipients and none of the controls had an at least fourfold rise in neutralizing antibodies to either HIV-1MN, HIV-1RF, or HIV-1(4489-5) laboratory-adapted HIV isolates. 3H-Thymidine incorporation assays of peripheral blood mononuclear cells increased at least fivefold over the baseline stimulation index to at least one of the immunogen peptides in two consecutive post-immunization timepoints in five out of eight C4-V3 PV recipients versus none of the controls. CD4 cell counts and plasma HIV RNA levels did not change in patients who received either C4-V3 PV or adjuvant alone. Adverse events consisted primarily of grade 1 injection site reactions in six subjects (four C4-V3 recipients, two controls). CONCLUSIONS: C4-V3 PV synthetic peptides demonstrated both immunogenicity and safety in HIV-infected patients.

Keywords: CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE Adult Amino Acid Sequence Antigens, CD/ANALYSIS AIDS Vaccines/ADVERSE EFFECTS/*IMMUNOLOGY Cell Line, Transformed Enzyme-Linked Immunosorbent Assay Female Human HIV Antibodies/BLOOD HIV Envelope Protein gp120/ADVERSE EFFECTS/*IMMUNOLOGY HIV Infections/IMMUNOLOGY/*PREVENTION & CONTROL/VIROLOGY HLA-B7 Antigen/*IMMUNOLOGY Intradermal Tests Lymphocyte Subsets/IMMUNOLOGY Lymphocytes/IMMUNOLOGY Male Middle Age Molecular Sequence Data Neutralization Tests Pilot Projects RNA, Viral/BLOOD Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S. T-Lymphocytes, Cytotoxic/IMMUNOLOGY Vaccines, Synthetic/ADVERSE EFFECTS/*IMMUNOLOGY
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A9911065

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