IMMUNIZATION WITH RECOMBINANT P17 P24-TY VIRUS-LIKE PARTICLES IN HUMAN IMMUNODEFICIENCY VIRUS-INFECTED PERSONS/

In studies of the natural history of human immunodeficiency virus type 1 (HIV-1) infection, it has been repeatedly shown that higher-titer a ntibody responses to the HIV gag p24 protein correlate with less rapid disease progression. In HIV-negative persons, immunization with HIV-1 p17/p24:Ty virus-like particles (p24-VLP) induced humoral and cellula r immune responses to p24. This construct was therefore studied as a p otential immunotherapeutic agent with the objective of augmenting the immune response to p24 in a double-blind placebo-controlled trial invo lving 74 p24 antibody-positive, asymptomatic HIV-l-infected subjects w ith CD4 cell counts >350/mm(3). Immunization with p24-VLP was generall y well tolerated. Immunization with p24-VLP did not increase p24 antib ody levels and had no effect on CD4 cell counts or virus load. The fai lure to increase p24 antibody titers cannot entirely be explained by t he subjects' immunodeficiency because most generated an antibody respo nse to Ty, a yeast component of the immunogen.