title: Safety and immunogenicity of ALVAC vCP1452 and recombinant gp160 in newly human immunodeficiency virus type 1-infected patients treated with prolonged highly active antiretroviral therapy.
abstract: In order to boost immune responses in persons in whom highly active antiretroviral therapy (HAART) was initiated within 120 days of the onset of symptoms of newly acquired human immunodeficiency virus type 1 (HIV-1) infection, we administered vaccines containing a canarypox virus vector, vCP1452, with HIV-1 genes encoding multiple HIV-1 proteins, and recombinant gp160. Fifteen HIV-1-infected subjects who achieved sustained suppression of plasma viremia for at least 2 years were enrolled. While continuing antiretroviral therapy, each subject received at least four intramuscular injections of the vaccines on days 0, 30, 90, and 180. Adverse events were mild, with the most common being transient tenderness at the vCP1452 injection site. Of the 14 patients who completed vaccination, 13 had significant increases in anti-gp120 or anti-p24 antibody titers, and 9 had transient augmentation of their T-cell proliferation responses to gp160 and/or p24. HIV-1-specific CD8(+) T cells were quantified using an intracellular gamma interferon staining assay. Among 11 patients who had increased CD8(+) T-cell responses, seven had responses to more than one HIV-1 antigen. In summary, vaccination with vCP1452 and recombinant gp160 appears safe and immunogenic in newly HIV-1-infected patients on HAART.
authors.affiliation: Aaron Diamond AIDS Research Center, The Rockefeller University, 455 1st Avenue, 7th Floor, New York, NY 10016, USA.
authors.forename: Xia
authors.initials: X
authors.lastname: Jin
authors.forename: Murugappan
authors.initials: M
authors.lastname: Ramanathan
authors.forename: Shady
authors.initials: S
authors.lastname: Barsoum
authors.forename: Geoffrey R
authors.initials: GR
authors.lastname: Deschenes
authors.forename: Lei
authors.initials: L
authors.lastname: Ba
authors.forename: James
authors.initials: J
authors.lastname: Binley
authors.forename: Daryl
authors.initials: D
authors.lastname: Schiller
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Bauer
authors.forename: Donald C
authors.initials: DC
authors.lastname: Chen
authors.forename: Arlene
authors.initials: A
authors.lastname: Hurley
authors.forename: Lucette
authors.initials: L
authors.lastname: Gebuhrer
authors.forename: Raphaelle
authors.initials: R
authors.lastname: El Habib
authors.forename: Pierre
authors.initials: P
authors.lastname: Caudrelier
authors.forename: Michel
authors.initials: M
authors.lastname: Klein
authors.forename: Linqi
authors.initials: L
authors.lastname: Zhang
authors.forename: David D
authors.initials: DD
authors.lastname: Ho
authors.forename: Martin
authors.initials: M
authors.lastname: Markowitz
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology*; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D015483:HIV Antibodies / Q000097:blood; D019302:HIV Envelope Protein gp160 / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology*; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000276:immunology; D006801:Humans; D008297:Male; D012367:RNA, Viral / Q000097:blood; D011995:Recombination, Genetic; D013601:T-Lymphocytes / Q000276:immunology; D014611:Vaccination; D017778:Vaccines, Combined; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics / Q000276:immunology*
chemical_list: D016915:AIDS Vaccines; C078788:ALVAC vaccine; D015483:HIV Antibodies; D019302:HIV Envelope Protein gp160; D012367:RNA, Viral; D017778:Vaccines, Combined; D014765:Viral Vaccines