title: V beta 17 T cell receptor peptide vaccination in rheumatoid arthritis: results of phase I dose escalation study.
abstract: OBJECTIVE
  To determine whether modulation of activated T cells occurs in patients with rheumatoid arthritis (RA) after immunization with T cell receptor (TCR) V beta 17 peptides, a phase I trial was initiated to investigate the safety and feasibility of TCR peptide immunization as a therapeutic approach in RA.
  
  
  METHODS
  15 patients with moderate to severe RA were given an intramuscular injection of one of 4 doses (10, 30, 100, and 300 micrograms) of the V beta 17 peptide vaccination, followed by a booster injection of the same dose of vaccine 3 weeks later. Patients were followed for 48 weeks.
  
  
  RESULTS
  The product was well tolerated and no serious adverse events attributable to the vaccine were observed. This was an uncontrolled phase I trial, however; decreases in patients joint scores were observed at all followup visits starting at 4 weeks after primary immunization. Activated V beta 17 T cells (IL-2R+) in peripheral blood were decreased (> or = 20%) in 3/5 patients in the 100 micrograms group after initial measurement at Week 2 and 3/4 patients in the 300 micrograms group 3 weeks after immunization. Lymphocyte proliferation in response to the V beta 17 peptide was detected at 6 weeks or later after primary inoculation in 6/15 patients (40%) immunized.
  
  
  CONCLUSIONS
  Further controlled studies are required to assess the biologic and clinical efficacy of this treatment approach.
authors.affiliation: Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, USA.
authors.forename: L W
authors.initials: LW
authors.lastname: Moreland
authors.forename: L W
authors.initials: LW
authors.lastname: Heck
authors.forename: W J
authors.initials: WJ
authors.lastname: Koopman
authors.forename: P A
authors.initials: PA
authors.lastname: Saway
authors.forename: T C
authors.initials: TC
authors.lastname: Adamson
authors.forename: Z
authors.initials: Z
authors.lastname: Fronek
authors.forename: R D
authors.initials: RD
authors.lastname: O'Connor
authors.forename: E E
authors.initials: EE
authors.lastname: Morgan
authors.forename: J P
authors.initials: JP
authors.lastname: Diveley
authors.forename: S P
authors.initials: SP
authors.lastname: Richieri
authors.forename: D J
authors.initials: DJ
authors.lastname: Carlo
authors.forename: S W
authors.initials: SW
authors.lastname: Brostoff
mesh_terms: D000328:Adult; D000595:Amino Acid Sequence; D001172:Arthritis, Rheumatoid / Q000276:immunology / Q000628:therapy*; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007273:Injections, Intramuscular; D008213:Lymphocyte Activation; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D016693:Receptors, Antigen, T-Cell, alpha-beta / Q000276:immunology*; D013601:T-Lymphocytes / Q000276:immunology; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: D016693:Receptors, Antigen, T-Cell, alpha-beta; D014614:Vaccines, Synthetic