title: A phase I/IIa immunotherapy trial of HIV-1-infected patients with Tat, Rev and Nef expressing dendritic cells followed by treatment interruption.
abstract: In a phase I/IIa clinical trial, 17 HIV-1 infected patients, stable on cART, received 4 vaccinations with autologous dendritic cells electroporated with mRNA encoding Tat, Rev and Nef, after which cART was interrupted. Vaccination was safe and feasible. During the analytical treatment interruption (ATI), no serious adverse events were observed. Ninety-six weeks following ATI, 6/17 patients remained off therapy. Although induced and/or enhanced CD4(+) and CD8(+) T-cell responses specific for the immunogens were observed in most of the patients, we found no correlation with the number of weeks off cART. Moreover, CD4(+) T-cell counts, plasma viral load and the time remaining off cART following ATI did not differ from historical control data. To conclude, the vaccine was safe, well tolerated and resulted in vaccine-specific immune responses. Since no correlation with clinical parameters could be found, these results warrant further research in order to optimize the efficacy of vaccine-induced T-cell responses.
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Universitair Ziekenhuis Brussel, Brussels, Belgium. sabine.allard@uzbrussel.be
authors.forename: Sabine D
authors.initials: SD
authors.lastname: Allard
authors.forename: Brenda
authors.initials: B
authors.lastname: De Keersmaecker
authors.forename: Anna L
authors.initials: AL
authors.lastname: de Goede
authors.forename: Esther J
authors.initials: EJ
authors.lastname: Verschuren
authors.forename: Jeanette
authors.initials: J
authors.lastname: Koetsveld
authors.forename: Mariska L
authors.initials: ML
authors.lastname: Reedijk
authors.forename: Carolien
authors.initials: C
authors.lastname: Wylock
authors.forename: Annelies V
authors.initials: AV
authors.lastname: De Bel
authors.forename: Judith
authors.initials: J
authors.lastname: Vandeloo
authors.forename: Frank
authors.initials: F
authors.lastname: Pistoor
authors.forename: Carlo
authors.initials: C
authors.lastname: Heirman
authors.forename: Walter E P
authors.initials: WE
authors.lastname: Beyer
authors.forename: Paul H C
authors.initials: PH
authors.lastname: Eilers
authors.forename: Jurgen
authors.initials: J
authors.lastname: Corthals
authors.forename: Iman
authors.initials: I
authors.lastname: Padmos
authors.forename: Kris
authors.initials: K
authors.lastname: Thielemans
authors.forename: Albert D M E
authors.initials: AD
authors.lastname: Osterhaus
authors.forename: Patrick
authors.initials: P
authors.lastname: Lacor
authors.forename: Marchina E
authors.initials: ME
authors.lastname: van der Ende
authors.forename: Joeri L
authors.initials: JL
authors.lastname: Aerts
authors.forename: Carel A
authors.initials: CA
authors.lastname: van Baalen
authors.forename: Rob A
authors.initials: RA
authors.lastname: Gruters
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology*; D000328:Adult; D000368:Aged; D002478:Cells, Cultured; D003713:Dendritic Cells / Q000276:immunology*; D015694:Gene Products, rev / Q000276:immunology; D015696:Gene Products, tat / Q000276:immunology; D015658:HIV Infections / Q000276:immunology / Q000628:therapy*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007114:Immunization; D008297:Male; D008875:Middle Aged; D054311:nef Gene Products, Human Immunodeficiency Virus / Q000276:immunology
chemical_list: D016915:AIDS Vaccines; D015694:Gene Products, rev; D015696:Gene Products, tat; D054311:nef Gene Products, Human Immunodeficiency Virus