title: Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214.
abstract: The potential role of human immunodeficiency virus type 1 (HIV-1)-specific immune responses in controlling viral replication in vivo has stimulated interest in enhancing virus-specific immunity by vaccinating infected individuals with HIV-1 or its components. These studies were undertaken to define patient populations most likely to respond to vaccination, with the induction of novel HIV-1-specific cellular immune responses, and to compare the safety and immunogenicity of several candidate recombinant HIV-1 envelope vaccines and adjuvants. New lymphoproliferative responses (LPRs) developed in <30% of vaccine recipients. LPRs were elicited primarily in study participants with a CD4 cell count >350 cells/mm(3) and were usually strain restricted. Responders tended to be more likely than nonresponders to have an undetectable level of HIV-1 RNA at baseline (P=.067). Induction of new cellular immune responses by HIV-1 envelope vaccines is a function of the immunologic stage of disease and baseline plasma HIV-1 RNA level and exhibits considerable vaccine strain specificity.
authors.affiliation: University of Colorado Health Sciences Center, Denver, CO, USA. Robert.Schooley@uchsc.edu
authors.forename: R T
authors.initials: RT
authors.lastname: Schooley
authors.forename: C
authors.initials: C
authors.lastname: Spino
authors.forename: D
authors.initials: D
authors.lastname: Kuritzkes
authors.forename: B D
authors.initials: BD
authors.lastname: Walker
authors.forename: F A
authors.initials: FA
authors.lastname: Valentine
authors.forename: M S
authors.initials: MS
authors.lastname: Hirsch
authors.forename: E
authors.initials: E
authors.lastname: Cooney
authors.forename: G
authors.initials: G
authors.lastname: Friedland
authors.forename: S
authors.initials: S
authors.lastname: Kundu
authors.forename: T C
authors.initials: TC
authors.lastname: Merigan
authors.forename: M J
authors.initials: MJ
authors.lastname: McElrath
authors.forename: A
authors.initials: A
authors.lastname: Collier
authors.forename: S
authors.initials: S
authors.lastname: Plaeger
authors.forename: R
authors.initials: R
authors.lastname: Mitsuyasu
authors.forename: J
authors.initials: J
authors.lastname: Kahn
authors.forename: P
authors.initials: P
authors.lastname: Haslett
authors.forename: P
authors.initials: P
authors.lastname: Uherova
authors.forename: V
authors.initials: V
authors.lastname: deGruttola
authors.forename: S
authors.initials: S
authors.lastname: Chiu
authors.forename: B
authors.initials: B
authors.lastname: Zhang
authors.forename: G
authors.initials: G
authors.lastname: Jones
authors.forename: D
authors.initials: D
authors.lastname: Bell
authors.forename: N
authors.initials: N
authors.lastname: Ketter
authors.forename: T
authors.initials: T
authors.lastname: Twadell
authors.forename: D
authors.initials: D
authors.lastname: Chernoff
authors.forename: M
authors.initials: M
authors.lastname: Rosandich
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000163:Acquired Immunodeficiency Syndrome / Q000276:immunology / Q000628:therapy* / Q000821:virology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008213:Lymphocyte Activation; D008297:Male; D012367:RNA, Viral / Q000032:analysis; D014759:Viral Envelope Proteins / Q000276:immunology*
chemical_list: D016915:AIDS Vaccines; D012367:RNA, Viral; D014759:Viral Envelope Proteins