title: Utility of various commercially available human immunodeficiency virus (HIV) antibody diagnostic kits for use in conjunction with efficacy trials of HIV-1 vaccines.
abstract: There is a need for human immunodeficiency virus (HIV) screening assays which will distinguish uninfected HIV vaccine recipients from HIV-infected individuals. Commercial screening kits were used to test serum samples from low- and high-risk participants in clinical trials before and after immunization with various recombinant HIV type 1 (HIV-1) envelope glycoprotein 120 (gp120) candidate vaccines. All kits were 100% sensitive in detecting HIV infection. Both Murex Single Use Diagnostic System and United Biomedical, Inc., HIV type 1 or 2 (HIV-1/2) enzyme immunoassay (EIA) kits, which detect antibodies to HIV-1 gp41, were 98 to 100% specific when used to screen baseline or recombinant gp120-vaccinated populations as vaccine-induced antibodies to gp120 were nonreactive in these tests. The Abbott HIVAB HIV-1 EIA (lysate of whole infected cells, reactive with anti-gp120 antibodies) gave high levels of reactivity due to vaccine-induced antibodies and a high baseline rate of false positives (12 of 83) among nonvaccinated high-risk volunteers. Assays containing only gp41 and p24 solid-phase components are compatible with gp120-based vaccines but are unlikely to be useful in a similar role for vaccines containing gp160, gp41, or gp120 plus p24 antigens. Efficacy trials must be designed in concert with available diagnostic screening assays to avoid problems caused by vaccine-induced seroconversion in high-risk populations.
authors.affiliation: Center for Immunization Research, Johns Hopkins School of Hygiene and Public Health, Baltimore, Maryland 21205, USA.
authors.forename: D H
authors.initials: DH
authors.lastname: Schwartz
authors.forename: A
authors.initials: A
authors.lastname: Mazumdar
authors.forename: S
authors.initials: S
authors.lastname: Winston
authors.forename: S
authors.initials: S
authors.lastname: Harkonen
mesh_terms: D016915:AIDS Vaccines / Q000097:blood* / Q000276:immunology; D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis* / Q000276:immunology; D015483:HIV Antibodies / Q000097:blood; D015488:HIV Antigens / Q000097:blood; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D011933:Reagent Kits, Diagnostic; D016036:Seroepidemiologic Studies
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; D015488:HIV Antigens; D011933:Reagent Kits, Diagnostic