title: Evaluation of monoclonal antibodies to human immunodeficiency virus type 1 primary isolates by neutralization assays: performance criteria for selecting candidate antibodies for clinical trials. AIDS Clinical Trials Group Antibody Selection Working Group.
abstract: A collaborative study was organized to identify monoclonal antibodies (MAbs) that may be broadly and potently neutralizing for a panel of human immunodeficiency virus type 1 (HIV-1) low-passaged adult and pediatric primary isolates in peripheral blood mononuclear cells. Five laboratories evaluated a coded panel of seven human MAbs to HIV-1 subtype B envelope V3, CD4 binding region, gp41, and other conformationally sensitive determinants. Each laboratory measured neutralizing activity of the MAbs against the laboratory isolate HIV(MN) and a panel of 9 subtype B primary isolates. Antibodies were classified as suitable candidates for future clinical studies if they could neutralize at least half of the 9 primary isolates at a concentration of < or = 25 microg/mL for 90% viral inhibition. The study identified three MAbs that met stated performance criteria: IgG1b12, 2G12, and 2F5. These results may provide a rationale for examining the clinical efficacy, either singly or in combination, of the three MAbs.
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20852, USA.
authors.forename: M P
authors.initials: MP
authors.lastname: D'Souza
authors.forename: D
authors.initials: D
authors.lastname: Livnat
authors.forename: J A
authors.initials: JA
authors.lastname: Bradac
authors.forename: S H
authors.initials: SH
authors.lastname: Bridges
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000276:immunology; D000328:Adult; D000595:Amino Acid Sequence; D000911:Antibodies, Monoclonal / Q000097:blood; D000918:Antibody Specificity; D015703:Antigens, CD / Q000502:physiology; D015704:CD4 Antigens / Q000502:physiology; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods; D000939:Epitopes / Q000032:analysis; D015483:HIV Antibodies / Q000097:blood; D019302:HIV Envelope Protein gp160 / Q000737:chemistry / Q000276:immunology*; D015700:HIV Envelope Protein gp41 / Q000737:chemistry / Q000276:immunology*; D006679:HIV Seropositivity / Q000097:blood / Q000276:immunology*; D015497:HIV-1 / Q000145:classification* / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood / Q000145:classification; D008969:Molecular Sequence Data; D009500:Neutralization Tests / Q000592:standards*; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D015703:Antigens, CD; D015704:CD4 Antigens; D000939:Epitopes; D015483:HIV Antibodies; D019302:HIV Envelope Protein gp160; D015700:HIV Envelope Protein gp41; D007074:Immunoglobulin G